FDA WARNING_LETTER - Market of Choice, LLC - January 14, 2021

On June 1, 2021, the FDA issued a Warning Letter to a food manufacturing facility in Eugene, Oregon, following an inspection from December 2020 to January 2021. The inspection was prompted by a Class I recall of Sour Cherry Baked Brie due to undeclared almond allergen.

The FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). The recalled product was misbranded under section 403(w) of the Act [21 U.S.C. § 343(w)] for failing to declare a major food allergen.

Key violations include: 1. **Inadequate Allergen Hazard Analysis:** The facility failed to identify undeclared allergens (tree nuts, peanuts, milk, eggs, soy, wheat) as a significant hazard requiring preventive controls, despite using them in production. A recipe change adding almonds to Sour Cherry Baked Brie was not communicated to retail stores, leading to the recall. The firm has had six recalls involving undeclared allergens in the past five years. Submitted corrective actions, like a "New Product Label Verification Checklist," did not address the root cause (failure to update electronic allergen declarations after reformulations) and lacked monitoring, corrective action, or verification procedures. A revised hazard analysis for allergens was not submitted. 2. **Inadequate Environmental Path