FDA WARNING_LETTER - LaMarquise Inc. - June 08, 2018

The FDA inspected La Marquise, Inc.'s bakery and central kitchen from June 4-8, 2018, focusing on Ready-to-Eat (RTE) cream-filled eclairs. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117), leading to a determination that food was adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Failure to comply with preventive controls is also prohibited by Section 301(uu). Key deficiencies included the firm's failure to prepare and implement a written food safety plan for RTE products, as required by 21 CFR § 117.126, which should address hazards like environmental pathogens and food allergens. Additionally, several Current Good Manufacturing Practice violations were observed: equipment and utensils were not adequately cleanable or maintained (21 CFR 117.40(a)(1)); non-food contact surfaces were not cleaned sufficiently (21 CFR 117.35(e)); personnel failed to conform to hygienic practices, including improper handwashing and personal item storage (21 CFR 117.10(b)); and temperature controls for foods supporting rapid microbial growth were inadequate, with cooler records showing frequent temperature excursions (21 CFR 117.80(b)(3)). An FDA Form 483 was issued, but no response has been received. La Marquise, Inc. must promptly correct these violations and submit a written response within 15 working days, detailing corrective actions and prevention strategies. Failure to comply may result in regulatory actions such as seizure or injunction, and the assessment of re-inspection fees.