Loading…
Langlinais' Baking Company, a ready-to-eat bakery in Lafayette, Louisiana, manufactured breads and rolls under insanitary conditions that posed contamination and health risks, violating Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls requirements under 21 CFR Part 117. FDA investigators found during a November 2021 inspection that the company failed to conduct adequate hazard analysis for its RTE products to identify known or reasonably foreseeable hazards requiring preventive controls. The facility's products were determined to be adulterated because they were prepared, packed, or held under conditions whereby they may have become contaminated with filth or rendered injurious to health. As of the March 2022 warning letter issuance, the company had not responded to the FDA Form 483 inspectional observations issued at the conclusion of the inspection.