Month: August 2018

FDA Advisory NO. 2018-240 Termination of the Voluntary Recall of  AV-Set B DT INF-E Blood Tubing System with DVR No. 8574 (Article No. AP16641)

The Food and Drug Administration (FDA) informs the public that Fresenius Medical Care Philippines, Inc., Marketing Authorization Holder (MAH), has reported that it has completed the recall and removal of AV-Set B DT INF-E Blood Tubing System (see Figures 1 and 2) with DVR No. 8574 (Article No. AP16641) from the Philippine market.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-240

 

/ In General Advisories / By FDA_Admin2 / Comments Off on FDA Advisory NO. 2018-240 Termination of the Voluntary Recall of  AV-Set B DT INF-E Blood Tubing System with DVR No. 8574 (Article No. AP16641)

FDA Advisory No. 2018-236 Public Health Warning Against the Purchase and Use of Unregistered Medical Devices (Weckstat Skin Staple Remover and Weck Visistat 35W Disposable Skin Stapler with 35 Wide Staples)

The Food and Drug Administration (FDA) advises all concerned healthcare professionals and the public against the purchase and use of the following medical device products:

FDA post-marketing surveillance activities have verified that Weckstat Skin Staple Remover (see Figure 1) and Weck Visistat 35W Disposable Skin Stapler with 35 Wide Staples (see Figure 2) have not gone through the registration process of the agency and have not been issued with Certificate of Product Registration (CPR).

Pursuant to the provisions of  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 any health product without the proper authorization are prohibited.

Since the abovementioned products did not undergo the evaluation process of the FDA, the agency cannot guarantee their quality and safety.

In this regard, the public is hereby advised not to purchase the above-mentioned violative products. All concerned establishments are warned not to advertise, sell or distribute the said products until such have been issued with the corresponding Certificate of 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 email us at [email protected]. To report continuous sale or distribution of the above medical devices, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or email us via [email protected], or call the Center for Device Regulation, Radiation Health, and Research at (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

 

 

/ In Device Advisories / By FDA_Admin2 / Comments Off on FDA Advisory No. 2018-236 Public Health Warning Against the Purchase and Use of Unregistered Medical Devices (Weckstat Skin Staple Remover and Weck Visistat 35W Disposable Skin Stapler with 35 Wide Staples)

Department Memorandum No. 2018-0232 Reiteration of the CSC-DOH Joint Memorandum Circular No. 2010-010 on the “Protection of the bureaucracy against tobacco industry interference”

This is to reiterate the Policy of the Department of Health (DOH) and the Civil Service Commission (CSC) on the Protection of the Bureaucracy Against Tobacco Industry Interference (CSC-DOH JMC 2010-01).

DM2018-0232

/ In General Announcements / By FDA_Admin2 / Comments Off on Department Memorandum No. 2018-0232 Reiteration of the CSC-DOH Joint Memorandum Circular No. 2010-010 on the “Protection of the bureaucracy against tobacco industry interference”

FDA Advisory No. 2018-241 Submissions under the Director-General’s Project Backlog

To Facilitate the processing of applications under the “Project Backlog” of the Director-General, and to address the problem on the numerous “incomplete”, “unidentified  and “unmatched” applications lodged at the FDA electronic portal (e-portal) – Which were mixed with other completed applications, applicants with pending applications lodged at the FDA e-portal before February 1, 2018 (LTO, CPR and PN, as enumerated above), are advised to confirm their application by filling-up the details required in this link: http://bit.ly/fda_zero_backlog

Last day of confirmation of the covered applications (to be included in the Project Backlog) will be on 25 August 2018 (Saturday), at 11:59 o’clock in the evening.

Applications for authorizations lodged at the FDA e-portal before 1 February 2018, which are not confirmed by 25 August 2018, shall be processed accordingly once confirmed. Confirmation shall only be accepted until 31 December 2018. Thereafter, all unconfirmed applications shall be deemed abandoned.

Submission of falsified, fictitious, misleading and/or fake requirements (information or document) shall be a ground for the immediate disapproval and revocation of the application for authorization/s secure a forfeiture of any fees paid, without prejudice to the filling of the appropriate criminal, civil and administrative charges against the erring QPIRA and/or the applicant for authorization.

Queries and clarifications may be sent to [email protected]

For your information, guidance and compliance.

FDA Advisory No. 2018-241

FDA Advisory No. 2018-239 Public Health Warning Against the Purchase and Use of Unregistered Medical Devices included in Johnson & Johnson First Aid To Go

The Food and Drug Administration (FDA) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical devices included in Johnson & Johnson First Aid To Go which are shown below:

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical devices have not gone through the registration process of the agency and have 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 these unregistered medical devices 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 hazards to the consuming public.

Furthermore, the FDA, in coordination with the Market Authorization Holder (MAH), Johnson & Johnson Philippines, Inc., has verified that the above-stated medical device products are counterfeit.

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 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. 2018-239

 

/ In General Advisories / By FDA_Admin2 / Comments Off on FDA Advisory No. 2018-239 Public Health Warning Against the Purchase and Use of Unregistered Medical Devices included in Johnson & Johnson First Aid To Go

FDA Advisory No. 2018-238 Public Health Warning Against the Purchase and Use of Unregistered Medical Device Products:

  1. Elastic Bandage 3”
  2. Elastic Bandage 4”

The Food and Drug Administration (FDA) hereby advises the general public and healthcare professionals against the purchase and use of the following medical device products:

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device 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.

In this regard, the public is hereby advised not to purchase and use the above-mentioned products and to be vigilant against the medical device products that are not registered with the FDA.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold in any market.

For more information and inquiries, please email us at [email protected] or call the Product Research and Development Division – Center for Device Regulation, Radiation Health and Research of the FDA at telephone no. (02) 857-1900 loc. 8301.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-238

FDA Advisory No. 2018-237 Lifting the Advisory of Indoplas Infrared Ear Thermometer under FDA Advisory No. 2018-120 re: “PUBLIC HEALTH WARNING AGAINST THE PURCHASE AND USE OF THE UNREGISTERED MEDICAL DEVICE PRODUCT (INDOPLAS INFRARED EAR THERMOMETER)”

The Food and Drug Administration (FDA) informs the public that the advisory on the medical device product “Indoplas Infrared Ear Thermometer” under FDA Advisory No. 2018-120 dated 02 April 2018 is hereby lifted pursuant to the compliance of the market authorization holder to existing and applicable laws, rules, and regulations.

The above-mentioned medical device product is REGISTERED with Certificate of Product Registration No. MDR-06882 valid until 29 June 2019 under company Indoplas Philippines, Inc.

The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to existing laws, rules, and regulations.

For more information and inquiries, please e-mail us at [email protected] or call the Center for Device Regulation, Radiation Health, and Research at (02) 857-1900 local 8301. To report sale or distribution of any unregistered medical device products, kindly email us via [email protected].

FDA Advisory No. 2018-237

/ In General Advisories / By FDA_Admin2 / Comments Off on FDA Advisory No. 2018-237 Lifting the Advisory of Indoplas Infrared Ear Thermometer under FDA Advisory No. 2018-120 re: “PUBLIC HEALTH WARNING AGAINST THE PURCHASE AND USE OF THE UNREGISTERED MEDICAL DEVICE PRODUCT (INDOPLAS INFRARED EAR THERMOMETER)”

Follow-Ups, Inquiries and Face-to-face interactions

For effective and efficient public service delivery, the CDRR hereby prescribes the following guidelines for making follow-ups:

  1. Status of applications may checked through the “Doctrack Staus” via FDA website https://ww2.fda.gov.ph/index.php/doctrack-status-know-the-status-of-your-application
  2. Follow-ups may be done by submitting Follow-up forms (attached as Annex A) via designated drop box assigned in the Food and Drug Action Center (FDAC). In view of this, the FDAC shall no longer receive follow-up letters from stakeholders.
  3. Follow-up forms may be submitted daily from Monday to Friday, 8:00am to 5:00pm.
  4. No Face-to-face interaction is allowed for follow-ups.

Submission of technical inquiry forms shall be covered in a separate issuance.

This shall take effect immediately are hereby replaced.

Follow-ups Inquiries and Face-to-face interactions

Schedule of CFRR QPIRA Regional Seminars

Schedule of CFRR QPIRA Regional Seminars

Please be informed of the schedule of Center for Food Regulation and Research (CFRR) Seminars for 3rd and 4th Quarter of 2018:

Course Title Date Venue
CFRR QPIRA Seminar for North Luzon 30-31 Aug 2018 Ilocos Suir
CFRR QPIRA Seminar for Mindanao 25-26 Oct 2018 Cagayan de Oro

Please refer to FDA Circular 2018-005 dated 16 March 2018 or FDA Academy website (www.fda.gov.ph/academy) for seminar/course registration procedure and training activity details. For inquiries, please call the FDA Academy at telephone number (02) 877 0259 or email at [email protected] and [email protected]

SCHEDULE OF CFRR QPIRA

 

FDA Cloud Migration

Please be advised that ICTMD will conduct migration activity (from FDA Server to a Cloud System) starting today 03 August 2018 (6pm) to 5 August 2018 (5pm). Due to this activity, we regret to inform you that the FDA Inventory System (FIS), e-portal, Zimbra (FDA Email System), and the FDA Website will not be available during this period.

We do apologize for the inconvenience. We are strongly committed to serve you better

Thank you very much for your kind understanding.

Schedule of CCRR Seminars

Please be informed of the schedule of Center for Cosmetics Regulation and Research (CCRR) seminars for the 3rd and 4th Quarter of 2018

COURSE TITLE DATE VENUE
 13 ASEAN Modules and GMP Modules for Cosmetic Traders 4-5 Sep 2018 Davao City
CCRR Cosmetics QPIRA Seminar 4-5 Sep 2018 Davao City
CCRR Cosmetics QPIRA Seminar 2-3 Oct 2018 Metro Manila
CCRR Household and Urban Hazardous Substance (HUHS) QPIRA Seminar 6-7 Nov 2018 Metro Manila

Please refer to FDA Circular No. 2018-005 dates 16 March 2018 or FDA Academy Website (www.fda.gov.ph/academy) for the seminar/course registration procedure and training activity details. For inquiries, please call tha FDA Academy at telephone number (02) 877 0259 or email at [email protected] and [email protected]

Schedule of CCRR Seminars

Reschedule of CCRR ASEAN-GMT-CMT (MIN) Seminar in Davao City

Please be informed that the Center for Cosmetic Regulation and Research (CCRR) Seminar entitled 13 ASEAN Modules and GMP Modules for Cosmetics Manufacturers and Traders, COURSE CODE: ASEAN-GMT-CMT (MIN), scheduled on 9-10 August 2018 in Davao City shall be rescheduled to 4-5 September 2018 due to low number of course participants that registered in the course.

Rest assured that all changes and concerns of the registered participants of this seminar shall be attended by the FDA Academy staff. For inquiries, please call the FDA Academy at telephone number (02) 877 0259 or email at [email protected]

Reschedule of CCRR ASEAN-GMP-CMT (MIN) Seminar in Davao City

FDA Advisory No. 2018-224 Public Health Warning Against the Purchase and Use of Unregistered Medical Device Secure Blood Lancets

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

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device product have not gone through the registration process of the agency and have 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 have 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 products 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 products until they have 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. 2018-224

FDA Advisory No. 2018-233 Dissemination of ASEAN Post-Marketing Alert System (PMAS) Report on Adulterated Cosmetic Products With the Reference No. (11)/MOH/DPS/PMAS/072018)

The Food and Drug Administration (FDA) hereby issues this public health warning to inform the public of the ASEAN Post-Marketing Alert System (PMAS) report on the following cosmetic products:

BRAND / PRODUCT NAME FINDINGS
1. Dnars Dinar Cream Presence of MERCURY
2. Dnars Honey Cream Presence of HYDROQUINONE and TRETINOIN

The aforementioned products have been tested by the Department of Pharmaceutical Services, Ministry of Health, Brunei Darussalam as part of their post-marketing surveillance activities and results of the laboratory analyses show that these products are not compliant with the technical standards set forth by the ASEAN Cosmetic Directive (ACD).

Product #1 has been verified to contain mercury beyond the maximum allowed limit of 1 part per million (ppm).  Mercury is a naturally occuring heavy metal which is known to be severely hazardous to health even in small amount. People exposed to mercury exhibits symptoms including but not limited to tremors, numbness and tingling in hands and feet, gingivitis or inflammation of the gums, pink discolouration of the hands and feet especially in children, irritability, and photophobia or sensitivity to light. Nursing mothers are doubly vulnerable because mercury are passed on to nursing babies through breast milk which can affect the baby’s development.

Product #2, on the other hand, has been found to contain hydroquinone and tretinoin, both of which are no longer allowed to be part of a cosmetic product and are classified as drug products in the Philippines because of its multiple serious adverse effects (i.e. sensitivity to light, skin redness and permanent skin discoloration) when used indiscriminately. Additionally, tretinoin may also cause harm to developing fetus. Women planning to get pregnant or are already expecting are strongly advised to avoid using products containing tretinoin.

Because of the hazards posed by the aforementioned products, the public is strongly advised to be vigilant and report to FDA through any of the following channels any encounter with these products:

  1. Send an e-mail via [email protected]
  2. Call the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8107 or 8113
  3. Utilize the agency’s online reporting facility, eReport, at www2.fda.gov.ph/ereport.

Furthermore, the public is also advised to only buy cosmetic products that have been notified with FDA. If unsure of a product’s notification status, consumers may verify whether the product is authorized by FDA through the Search engine embedded in the FDA website accessible at www.fda.gov.ph. For more information and inquiries, please e-mail us at [email protected] or call the CCRR hotline.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-233

/ In General Advisories / By FDA_Admin2 / Comments Off on FDA Advisory No. 2018-233 Dissemination of ASEAN Post-Marketing Alert System (PMAS) Report on Adulterated Cosmetic Products With the Reference No. (11)/MOH/DPS/PMAS/072018)

FDA Advisory No. 2018-232 Dissemination of ASEAN Post-Marketing Alert System (PMAS) Report on Adulterated Cosmetic Products With the Reference No. (12)/MOH/DPS/PMAS/072018)

The Food and Drug Administration (FDA) hereby issues this public health warning to inform the public of the ASEAN Post-Marketing Alert System (PMAS) report on the following cosmetic products:

BRAND / PRODUCT NAME FINDINGS
1. Tati 5 in 1 Skincare New & Improved Glow of Lasting Beauty – Ultra Night Cream Presence of MERCURY
2. Tati 5 in 1 Skincare New & Improved Glow of Lasting Beauty – Ultra Treatment Cream Presence of HYDROQUINONE and TRETINOIN
3. GP Cream Night Cream Presence of HYDROQUINONE and TRETINOIN

The aforementioned products have been tested by the Department of Pharmaceutical Services, Ministry of Health, Brunei Darussalam as part of their post-marketing surveillance activities and results of the laboratory analyses show that these products are not compliant with the technical standards set forth by the ASEAN Cosmetic Directive (ACD).

Product #1 has been verified to contain mercury beyond the maximum allowed limit of 1 part per million (ppm).  Mercury is a naturally occuring heavy metal which is known to be severely hazardous to health even in small amount. People exposed to mercury exhibits symptoms including but not limited to tremors, numbness and tingling in hands and feet, gingivitis or inflammation of the gums, pink discolouration of the hands and feet especially in children, irritability, and photophobia or sensitivity to light. Nursing mothers are doubly vulnerable because mercury are passed on to nursing babies through breast milk which can affect the baby’s development.

Products #2 and #3, on the other hand, have been found to contain hydroquinone and tretinoin, both of which are no longer allowed to be part of a cosmetic product and are classified as drug products in the Philippines because of its multiple serious adverse effects (i.e. sensitivity to light, skin redness and permanent skin discoloration) when used indiscriminately. Additionally, tretinoin may also cause harm to developing fetus. Women planning to get pregnant or are already expecting are strongly advised to avoid using products containing tretinoin.

Because of the hazards posed by the aforementioned products, the public is strongly advised to be vigilant and report to FDA through any of the following channels any encounter with these products:

  1. Send an e-mail via [email protected]
  2. Call the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8107 or 8113
  3. Utilize the agency’s online reporting facility, eReport, at www2.fda.gov.ph/ereport.

Furthermore, the public is also advised to only buy cosmetic products that have been notified with FDA. If unsure of a product’s notification status, consumers may verify whether the product is authorized by FDA through the Search engine embedded in the FDA website accessible at www.fda.gov.ph. For more information and inquiries, please e-mail us at [email protected] or call the CCRR hotline.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-232

/ In General Advisories / By FDA_Admin2 / Comments Off on FDA Advisory No. 2018-232 Dissemination of ASEAN Post-Marketing Alert System (PMAS) Report on Adulterated Cosmetic Products With the Reference No. (12)/MOH/DPS/PMAS/072018)

FDA Advisory No. 2018-235 Public Health Warning Against the Purchase and Use of Unregistered BEST AID BRAND ADHESIVE BANDAGES as Medical Device Product

The Food and Drug Administration (FDA) advises the general public and all healthcare professionals, establishment and general consuming public against the purchase and use of the Best Aid Brand Adhesive Bandages as unregistered medical device product:

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device product have not gone through the registration process of the agency and have 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 have 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 products 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 products until they have 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. 2018-235

/ In General Advisories / By FDA_Admin2 / Comments Off on FDA Advisory No. 2018-235 Public Health Warning Against the Purchase and Use of Unregistered BEST AID BRAND ADHESIVE BANDAGES as Medical Device Product