Month: February 2019

POSTPONEMENT OF GMP-FMT-NCR ON 5 MARCH 2019

Please be informed that the conduct of GMP-FMT in NCR (Course Code: GMP-FMT-NCR) scheduled on 5 March 2019 shall be postponed due to very low number of course participants that registered in the course. All registered and assessed participants will be accommodated on the next training schedule on 18 September 2019.

Rest assured that all changes and concerns of the registered participants of this seminar shall be attended to by the FDA Academy staff. For more information and update regarding this seminar, please visit the FDA website, www.fda.gov.ph. Please be guided accordingly.

For inquiries and other concerns, you may reach the FDA Academy thru:

Telephone Number: (02) 877 0259

Email Address: [email protected] or [email protected]

POSTPONEMENT OF GMP-FMT-NCR ON 5 MARCH 2019

FDA Advisory No. 2018-274-B || Amendment to FDA Advisory No. 2018-274 “Public Health Warning Against the Use of Cosmetic Products Containing Banned Ingredient/s (Batch 10)” Dated 10 September 2018

The Food and Drug Administration (FDA) hereby advises the public that the cosmetic products listed in FDA Advisory No. 2018-274 “Public Health Warning Against the Use of Cosmetic Products Containing Banned Ingredient/s (Batch 10)” dated 10 September 2018 is amended to remove the product, BEAUCHE CLARIFYING SOLUTION.

The Market Authorization Holder (MAH), Beauché International by Conchita Inc., has conducted a voluntary recall and complete disposal of specific batch of the cosmetic product affected by the said Advisory whose particulars/details are provided in the picture:

According to the MAH,  the inventory with identified lot/batch number, manufacturing and expiration date are no longer available in the market and have been voluntarily recalled and properly disposed of.

The MAH is urged to strictly comply with FDA implemented laws, rules and regulations and to closely monitor the marketing of the subject products. Nothing in this Advisory shall preclude the FDA from pursuing further actions, as it may deem necessary against the MAH, should the subject products be confirmed to contain banned ingredients.

In view thereof, FDA Advisory No. 2018-274 is hereby updated accordingly. For more information and inquiries, please e-mail us at [email protected]. To report any suspicious activity and/or product, kindly e-mail us via [email protected], call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8113/8017.

Dissemination of the information to all concerned is requested

FDA Advisory No. 2018-274-B

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2018-274-B || Amendment to FDA Advisory No. 2018-274 “Public Health Warning Against the Use of Cosmetic Products Containing Banned Ingredient/s (Batch 10)” Dated 10 September 2018

FDA Advisory No. 2018-275-A || Amendment to FDA Advisory No. 2018-275 “Public Health Warning Against the Use of Cosmetic Products Containing Banned Ingredient/s (Batch 9)” Dated 10 September 2018

The Food and Drug Administration (FDA) hereby advises the public that the cosmetic products listed in FDA Advisory No. 2018-275 “Public Health Warning Against the Use of Cosmetic Products Containing Banned Ingredient/s (Batch 9)” dated 10 September 2018 is amended to remove the product, BEAUCHE REJUVENATING CREAM.

The Market Authorization Holder (MAH), Beauché International by Conchita Inc., has conducted a voluntary recall and complete disposal of specific batch of the cosmetic product affected by the said Advisory whose particulars/details are provided in the picture:

According to the MAH,  the inventory with identified lot/batch number, manufacturing and expiration date are no longer available in the market and have been voluntarily recalled and properly disposed of.

The MAH is urged to strictly comply with FDA implemented laws, rules and regulations and to closely monitor the marketing of the subject products. Nothing in this Advisory shall preclude the FDA from pursuing further actions, as it may deem necessary against the MAH, should the subject products be confirmed to contain banned ingredients.

In view thereof, FDA Advisory No. 2018-275 is hereby updated accordingly. For more information and inquiries, please e-mail us at [email protected]. To report any suspicious activity and/or product, kindly e-mail us via [email protected], call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8113/8017.

Dissemination of the information to all concerned is requested

FDA Advisory No. 2018-275-A

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2018-275-A || Amendment to FDA Advisory No. 2018-275 “Public Health Warning Against the Use of Cosmetic Products Containing Banned Ingredient/s (Batch 9)” Dated 10 September 2018

FDA Advisory No. 2019-045 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Coralite® Bandages Sheer Extra Large”

The Food and Drug Administration (FDA) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical device product Coralite® Bandages Sheer Extra Large.

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device products has not gone through the registration process of the agency and has not been issued with the proper authorization in the form of Certificate of Product Registration. Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since this unregistered medical device has not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The consumption of such violative product may pose potential health hazards to the consuming public.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against medical device that might not be duly registered with FDA. Always check if a medical device has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments and/or entities are warned not to distribute the above-identified violative medical device product until it has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pusued.

All local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this product is not sold or made available in localities or areas or jurisdiction.

For more information and inquiries, please e-mail us at [email protected] To report continuous sale or distribution of the above unregistered medical device, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or email us via [email protected], or call us at the Center for Device Regulation, Radiation Health, and Research (CDRRHR) hotline (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-045

FDA Advisory No. 2019-044 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product (FOLEY CATHETER)

The Food and Drug Administration (FDA) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical device product FOLEY CATHETER:

FDA post-marketing surveillance (PMS) activities have verified that the above-mentioned medical device product has not gone through the registration process of the agency and has not been issued with proper authorization in the form of Certificate of Product Registration (CPR). Pursuant to Republic Act 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since this unregistered medical device has not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The consumption of such violative product may pose potential health hazards to the consuming public.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against medical device that might not be duly registered with FDA. Always check if a medical device has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments and/or entities are warned not to distribute the above-identified violative medical device product until it has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected] To report continuous sale or distribution of the above unregistered medical device, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-044

FDA Advisory No. 2019-043 || Public Health Warning Against the Use of Cosmetic Products Containing Banned Ingredient/s (Batch 2)

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following adulterated cosmetic products which tested positive for the presence of HYDROQUINONE, ingredient that is not allowed to be part of a cosmetic as per Annex II Part 1 of the ASEAN Cosmetic Directive (refer to the image below for the products particulars/details):

PRODUCT NAME PRODUCT DETAILS
NISCE PEEL WHITE CREAM Manufactured by/ Local Company Responsible for Placing the Product in the Market:

ETN Beauty Concepts, Inc.

Address:

TN Arcade Ortega St., San Fernando City, La Union

Country of Manufacture:

Not Indicated

Lot/Batch Number: 3803003

Mfg. Date: 06/18

Exp. Date: 12/19

SKIN MAGICAL REJUVENATING FACIAL TONER NO.1 Local Company Responsible for Placing the Product in the Market:

Skin Magical Beauty Products Trading

Address:

820 Tomas Claudio, Brgy. San Pedro, Morong Rizal

Country of Manufacture:

Not Indicated

Lot/Batch Number: SMT:010818

Mfg. Date: AUG.2018

Exp. Date: AUG.2020

 

Products containing Hydroquinone shall be classified as home remedy, over-the-counter, or prescription drug depending on the amount present as per Administrative Order No. 13 s. 1999.

Accordingly, because these products are not compliant with the existing standards, consumers should be vigilant against their purchase and use. The use of these products can pose potential health hazards to the consuming public and may result to adverse reactions including but not limited to skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the above, the public is advised not to purchase the aforementioned violative products. Moreover, the public is also advised to be vigilant against cosmetic products that might not be duly notified with FDA. Always check if a cosmetic product has been notified with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative cosmetic products until they have already been covered by the appropriate authorization (cosmetic notification), otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

To report any suspicious and/or illegal activity involving the said products, the public may contact FDA through its online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us at [email protected], or call the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8107/8113.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-043

FDA Advisory No. 2019-042 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) advises the public against the purchase and consumption of the following unregistered food products:

  1. AMERICA’S TOP CHOICE BEST RAMEN, CHICKEN FLAVOR
  2. AMERICA’S TOP CHOICE BEST RAMEN,SHRIMP FLAVOR
  3. AMERICA’S TOP CHOICE BEST RAMEN, BEEF FLAVOR
  4. TO-NE STRABERRY JUICE
  5. TO-NE GRAPE JUICE

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food products have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since unregistered food products have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazard to the consuming public.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at info[email protected]. To report continuous sale or distribution of the above unregistered food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-042

FDA Advisory No. 2019-041 || Public Health Warning Against the Use of Counterfeit Cosmetic Products (Batch 1)

The Food and Drug Administration (FDA) hereby advises the public against the purchase and use of RDL WHITENING TREATMENT™ DAY AND NIGHT CREAM 8 DAYS TREATMENT whose particulars/details are provided in the picture:

FDA, in coordination with the Market Authorization Holder (MAH), RDL Pharmaceutical Laboratory, has verified that the aforementioned cosmetic product is a COUNTERFEIT. According to the MAH, the company does not manufacture, distribute nor export the said cosmetic product.

Counterfeit products, not having gone through the required safety assessment and the verification process of the FDA, pose potential health hazards to the consuming public since their safety and purity cannot be guaranteed. The dangers/hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals such as lead and mercury. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including but not limited to skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the above, the public is advised to be vigilant against buying and using the aforementioned counterfeit cosmetic product. Moreover, the public is also advised to be vigilant against cosmetic products that might not be duly notified with FDA. Always check if a cosmetic product has been notified with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative cosmetic product, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that the product is not sold or made available in their localities or areas of jurisdiction.

To report any suspicious and/or illegal activity involving the said product, the public may contact FDA through its online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us at [email protected], or call the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8107/8113.

Dissemination of the information to all concerned is requested

FDA Advisory No. 2019-041

FDA Advisory No. 2019-040 || Public Health Warning Against the Unlicensed Establishment “Uplus Corporation”

The Food and Drug Administration (FDA) advises the general public against purchasing products from unlicensed company, Uplus Corporation, located at 430 Celery Road Building 4, FTI Complex, Taguig City.

Following R.A. No. 3720, as amended by R.A. No. 9711, and pursuant to the Administrative Order 2016-0003, all establishment that imports and sell medical device shall secure appropriate License to Operate (LTO) from FDA prior to engaging such activities. The issuance of LTO is a proof that the establishment is legitimate and complies with good distribution practices.

In view of these reports, FDA warns the public against purchasing from unauthorized distributors. Consumers availing products from these unauthorized distributors are at risk of buying counterfeit products.

To determine whether an establishment is licensed with the FDA, kindly validate with the FDA website. Just type in the name of the establishment in the search box (upper right corner).

The FDA has already initiated the conduct of investigation on the proliferation of medical devices being sold or offered for sale from unauthorized distributors.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that products from this distributor are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected] / [email protected] or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-040

FDA Advisory No. 2019-039 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) advises the public against the purchase and consumption of the following unregistered food supplements:

  1. MONCHERRY ANTI-MELASMA WHITENING CAPSULE L-GLUTATHIONE + COLLAGEN
  2. DETOXI SLIM PLUS+
  3. R.10 HERBAL FOOD SUPPLEMENT
  4. UNIFIED WELLNESS L-GLUTATHIONE WITH VIT. C, ALPHA LIPOIC ACID, AND ROSEHIP EXTRACT
  5. TEEGREEN CELL PROTECTOR
  6. EMVI MALUNGGAY HERBAL CAPSULE

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food supplements have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since unregistered food products have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazard to the consuming public.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the above unregistered food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-039

FDA Advisory No. 2019-038 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) advises the public against the purchase and consumption of the following unregistered food products:

  1. BODY BEAUTY 5 DAYS SLIMMING COFFEE
  2. BEAUTY MODEL SLIMMING CAPSULES
  3. JIE TOU QI SHI CAPSULE
  4. CHRISTOPHER’S LIVER & GALLBLADDER FORMULA VEGGIE CAPS
  5. YOUTHEORY RESVERATROL

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food products have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since unregistered food products have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazard to the consuming public.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the above unregistered food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-038

Guidelines for The Classification of Deficiencies Observed During Inspection of Drug Manufacturers

FDA CIRCULAR NO. 2019-003

14 FEB 2019

Subject:  GUIDELINES FOR THE CLASSIFICATION OF DEFICIENCIES OBSERVED DURING INSPECTION OF DRUG MANUFACTURE

 

I.  RATIONALE 

 

Republic Act (RA) No. 3720, as amended by RA No. 9711, declared it a policy of the State to adopt, support, establish, institutionalize, improve and maintain structures, processes, mechanisms and initiatives that are aimed, directed and designed to help establish and maintain an effective health products regulatory system.  Pursuant to the foregoing policy, the State, through the Food and Drug Administration, must enhance its regulatory capacity and strengthen its capability with regard to the inspection, licensing and monitoring of establishments, and the registration and monitoring of health products, such as drug products and drug manufacturers, respectively.

Consequently, and in order to achieve the objective of RA No. 9711 of ensuring the FDA’s monitoring and regulatory coverage over, and providing coherence in FDA’s regulatory system for drug manufacturers and drug products, it is imperative that classification of deficiencies noted during inspection of drug manufacturers is consistent, and drug manufacturers are guided with manufacturing practices considered non-compliant to FDA-implemented rules/ standards in the manufacture of drug products.

Finally, in compliance with the declared policy of the State laid down in Republic Act No. 11032 or the Ease of Doing Business and Efficient Government Service Delivery Act of 2018 to promote integrity, accountability, establish effective practices, aimed at efficient turnaround of the delivery of government services and the prevention of graft and corruption in government, the FDA is committed to take appropriate measures to promote transparency.

Hence, this Circular is hereby issued.

 

II.  OBJECTIVE

 

This Circular is issued to have uniform understanding in the classification of the noted non-conformances during inspection of drug manufacturers and provide guidelines to the drug manufacturing inspectorate service of the FDA’s Field Regulatory Operations Office, as well as drug manufacturers for uniformity of regulatory understanding consistent with the provisions of RA No. 3720, as amended by RA No. 9711, RA No. 11032, and relevant national and international standards and policies.

 

III.  SCOPE 

 

These guidelines shall apply to all local and foreign drug Good Manufacturing Practice (GMP) inspection, drug GMP inspectorate, and establishments manufacturing drugs including: household remedy, medicinal gas, traditional and herbal medicines, non-sterile, sterile, vaccines and biologicals, radiopharmaceuticals, blood and blood products and active pharmaceutical ingredients for human and animal use.

 

IV.  GUIDELINES 

 

For uniformity, efficiency and transparency, non-conformances observed during inspections are classified based on the following definitions:

  1. Critical deficiency – a deficiency which has produced, or may lead to, a significant risk of producing either a product which is harmful to the human or veterinary patient, or a product which could result in a harmful residue in a food producing animal.

It also covers findings of the manufacturer’s or its agent’s commission of fraud, misrepresentation or falsification of products, records or data, or withhold any relevant data contrary to the provisions of law, rules and regulations or appropriate standards.

  1. Major deficiency–a deficiency which indicates a major deviation from the terms of the marketing authorization/ product registration, PIC/S Good Manufacturing Practice guide and other internationally accepted standard; or which indicates a failure to carry out satisfactory procedures for release of batches of drugs; or

a combination of several “other” deficiencies, none of which on their own may be major, but which may together represent a major deficiency and should be explained and reported as such; or repetitive deviation for two or more consecutive inspections.

  1. Othersa deficiency which cannot be classified as either critical or major, but which indicates a departure from good manufacturing practice. A deficiency may be “other” either because it is judged as minor, or because there is insufficient information to classify it as major or critical.

 

For reference a list of observations classified according to the above definitions is attached as Annex A. The list is non-exhaustive and other observations may be added, removed, or re-classified as appropriate, subject to notice to the concerned stakeholders.

 

Deficiencies with upward-arrow marked (↑) are elevated to the next higher level of deficiency for findings noted in a sterile facility.

 

In case of findings classified as critical deficiency (ies) the establishment is directed to initiate outright, any or all of the following:

  1. Temporarily stop production of affected product line/s and further importation (in case of foreign audit findings) and/or distribution;
  2. Undertake or cause company-initiated recall of affected batches following existing FDA rules and procedure for product recall;
  3. Address the deficiencies, including submission of CAPA plan and objective evidence of compliance, not later than thirty (30) calendar days reckoned on the day following the receipt of the inspection report.

**For foreign drug GMP inspections with drug products already available in the Philippine market, submission of CAPA plan and objective evidence does not apply, and non- issuance of appropriate authorization is imperative as per FDA Circular 2014-016.

 

Apart from the foregoing, critical findings may result in the FDA imposing subsequent regulatory action, including disapproval of application, suspension or revocation of the issued authorization.

 

In case of major and other deficiencies, the inspector is authorized to direct the establishment to address the deficiencies, including the submission of CAPA Plan and objective evidence of compliance, not later than forty-five (45) calendar days reckoned on the day following the receipt of the inspection report.

 

 V.  REPEALING AND SEPARABILITY CLAUSES

 

Any provisions of existing FDA-issued Circulars or Memoranda that are inconsistent with this Circular are hereby repealed, withdrawn and/or revoked accordingly.

If any provision of this Circular or application of such provision to any circumstances is held invalid, the validity of the remainder of the provisions hereof not affected shall continue to be in effect.

 

VI.  EFFECTIVITY

 

This Circular shall take effect immediately.

 

NELA CHARADE G. PUNO, RPh

Director General

 

ATTACHMENTS:

FDA Advisory No. 2019-036 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) advises the public against the purchase and consumption of the following unregistered food products:

  1. PURE TURMERIC BY MAN-ATONG, SUYO, ILOCOS SUR
  2. MILING’S ASSORTED PULVURON
  3. PUREGOLD PISO GARANTISADO BLACK PEPPER CRACKED TIE
  4. JULIET’S SPECIAL MIX NUTS
  5. RA2IAH CANDY

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food products have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since unregistered food products have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazard to the consuming public.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the above unregistered food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8112.

Dissemination of the information to all concerned is requested.

 

FDA Advisory No. 2019-036