FDA WARNING_LETTER - Port Clyde Fresh Catch, Inc. - April 25, 2019

The FDA inspected Port Clyde Fresh Catch, Inc. from April 16-18 & 25, 2019, finding serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). This renders their refrigerated, ready-to-eat, cooked crabmeat and frozen, ready-to-eat crabmeat in vacuum packages adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include inadequate critical limits for cooking, cooling, and cumulative unrefrigerated processing time, failing to control pathogen growth and toxin formation. Specifically, internal cooking temperatures for several batches of crabmeat were insufficient, and the firm continued to process and ship these batches. The revised HACCP plan submitted by the firm lacked a time parameter for cooling and failed to identify Clostridium botulinum and allergen hazards. Corrective actions for critical control points were deemed inadequate as they did not ensure adulterated products would not enter commerce or that the cause of deviation would be corrected. The firm also failed to provide a detailed explanation of its cook process to ensure a 6-log reduction of Listeria monocytogenes.

Additionally, the firm failed to register its facility as required by Section 415 of the Act (21 U.S.C. § 350d) and 21 CFR Part 1, Subpart H. The