FDA Advisory No. 2019-228 || Public Health Warning Against the Purchase and Use of the Unregistered Health Related Device “Westinghouse 3 Stage Water Purification System”:

The Food and Drug Administration (FDA) warns the general public against the purchase and use of the unregistered health related device:

The FDA verified through post-marketing surveillance that the above mentioned health related

device is not registered and the Certificate of Heath Related  Device Registration (CHRDR) has not yet

been issued. Pursuant to the 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 is prohibited.

Since this unregistered health related device has not gone through evaluation process of the FDA,

the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to distribute, advertise the violative  product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative

health related device until CHRDR is issued, otherwise, regulatory actions and sanctions shall

be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement units in coordination with law

enforcement agencies and Local Government Units are requested to ensure that this product is

not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation,

Radiation Health and Research through e-mail at [email protected],or call (02) 857-1900 loc.

8301.

To report any sale or distribution of Unregistered health device, the Online reporting Facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

ATTACHMENT: FDA-Advisory-No-2019-228

 

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2019-228 || Public Health Warning Against the Purchase and Use of the Unregistered Health Related Device “Westinghouse 3 Stage Water Purification System”: