FDA WARNING_LETTER - Consernor

The FDA issued a Warning Letter to CONSERNOR S.A. (III) following a review of their HACCP plan for imported canned sardines, mackerel, and tuna. The review by the New York District Office identified serious deviations from the seafood HACCP regulation (21 CFR Part 123), rendering the firm's products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include the failure to conduct a proper hazard analysis for undeclared allergens like finfish and soy (21 CFR 123.6(a) and (c)(1)). The HACCP plan also contained inadequate critical limits for controlling scombrotoxin (histamine) formation, specifically regarding time between harvest and icing, fish receipt from vessels, decomposition detection, and refrigerated storage monitoring (21 CFR 123.6(c)(3)). Furthermore, monitoring procedures at the "Fish Reception (Factory) (CCP1)" critical control point were insufficient, lacking specified sample units for histamine testing (21 CFR 123.6(c)(4)). Lastly, predetermined corrective action plans for histamine formation were deemed inappropriate as they failed to address the root cause of deviations (21 CFR 123.7(b)). The FDA requires a written response within 15 working days, outlining specific corrective steps, including a revised HACCP plan, five consecutive days of completed monitoring records, and documentation of changes. Failure to comply may result in refusal of admission and detention without physical examination of their products.