FDA WARNING_LETTER - Vicrossano Inc. - July 09, 2013

The FDA inspected Vicrossano Inc. in Montreal, Canada, on July 8-9, 2013, identifying serious violations of Current Good Manufacturing Practice (CGMP) regulations, 21 CFR Part 110. Consequently, the firm's food products are deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The FDA issued an FDA-483, and despite the firm's email responses on July 24 and October 31, 2013, which included photos, the corrective actions were deemed inadequate. Key violations included failure to effectively exclude pests and protect against contamination (21 CFR 110.35(c)), insufficient cleaning frequency for food contact surfaces (21 CFR 110.35(d)), failure to maintain sanitary and repaired plant facilities (21 CFR 110.35(a)), inadequate facility construction for cleaning and repair of floors, walls, and ceilings (21 CFR 110.20(b)(4)), and lack of food handler training for 18 years (21 CFR 110.10(c)). The FDA requires a written response within 15 working days outlining specific corrective steps, including documentation of changes to cleaning/sanitizing SOPs and frequencies. Failure to adequately respond could lead to further action, including refusal of product admission under Section 801(a) and assessment of re-inspection fees under Section 743 of the Act.