Having found serious violations of CGMPs and Preventive Controls at a ready-to-eat bakery, FDA determined products to be adulterated due to insanitary conditions under which they may have become contaminated with filth or rendered injurious to health. The primary GMP concern noted was pests, including:
- Evidence of rodent and insect activity during the most recent inspection, which was a repeat from their last inspection 3 years ago.
- This led FDA to conclude that corrective actions are not implemented on a continual basis; and
- Corrective actions were deemed ineffective since pest activity persisted.
Adding to that, it was found that the facility did not renew its registration with the FDA’s Food Facility Registration (FFR) system during the required period. As required by the Bioterrorism Act of 2002 addition of section 415 to the FD&C Act, domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register with FDA between October 1-December 31 of each even-numbered year.
While FDA is under no legal obligation to warn firms of violations before taking enforcement action, warning letters are issued to give facility’s an opportunity to take voluntary corrective action before an enforcement action is implemented. However, a facility’s failure to take corrective action can lead to FDA enforcement actions including sequential or concurrent recall, seizure, injunction, administrative detention, civil money penalties and/or prosecution to achieve correction.
