FDA WARNING_LETTER - Portland Fish Exchange - March 06, 2014

The FDA inspected Portland Fish Exchange (6 Portland Fish Pier, Portland, ME) on February 25 and March 6, 2014, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Consequently, the firm's seafood products, including histamine-producing species like mackerel, bluefish, and tuna, are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Key violations include the failure to have a HACCP plan with adequate critical limits for scombrotoxin formation at the receiving critical control point (CCP) for scombroid species, as required by 21 CFR 123.6(c)(3), and not performing sensory exams. Additionally, the HACCP plan lacked proper monitoring procedures and frequencies for the receiving CCP (21 CFR 123.6(c)(4)), and the firm failed to implement its listed record-keeping system, resulting in missing monitoring records for internal temperatures of incoming fish (21 CFR 123.6(b) and (c)(7)). Finally, the firm did not maintain required sanitation control records for at least eight months, violating 21 CFR 123.11(c). The FDA requires a written response within fifteen working days outlining specific corrections, supported by documentation. Failure to correct these violations may lead to product seizure, injunction, and re-inspection fees.