FDA issues Product Recall Guidelines

The FDA recently issued Guidelines on Product Recall of health products, placing overall responsibility of conducting product recalls with the Market Authorization Holder (MAH).  In particular, MAHs are responsible for providing an appropriate product recall strategy and implementing the same.  The Guidelines also created a Product Recall Committee whose principal functions are to review “triggers” for product recall, issue recall resolutions and monitor recall implementation.

Contact Us

Betita Cabilao Casuela Sarmiento
Suite 1104, Page One Building
1215 Acacia Avenue
Madrigal Business Park, Ayala Alabang
Muntinlupa City 1780
Metro Manila, Philippines

Tel No. +63 2 555 1750
Email: info@bccslaw.com