FDA WARNING_LETTER - Langlinais’ Baking Company - November 05, 2021

The FDA inspected a ready-to-eat (RTE) bakery at 814 West Congress St, Lafayette, LA, from November 1-5, 2021, finding serious violations of the CGMP & PC rule (21 CFR Part 117). The facility manufactures various breads and rolls, including French Bread and Sweet Roll Hamburger Buns. The FDA determined the products are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Violations include: 1. **Hazard Analysis Deficiencies (21 CFR 117.130(a))**: * Failure to identify and evaluate undeclared allergens due to incorrect labeling at the packaging step. This was evidenced by a November 2021 recall of French Bread due to undeclared wheat and a lack of monitoring, corrective action, or verification in the "Allergen Control Program." * Failure to identify and evaluate allergen cross-contact at dough mixing and forming steps, particularly for milk-containing Sweet Roll Hamburger Buns sharing equipment with non-allergen products. The written "Allergen Control Program" lacked this control measure. * Failure to evaluate environmental pathogens (e.g., Salmonella) as a hazard requiring a preventive control at cooling and packaging steps for RTE products exposed to the environment.

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