FDA WARNING_LETTER - Fair Fish Co., Inc. - March 08, 2018

The FDA inspected Fair Fish Co., Inc. from February 27 to March 8, 2018, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's ready-to-eat, pasteurized canned crabmeat was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to take appropriate corrective action (21 CFR 123.7(a)):** On December 4, 2017, pasteurized canned crabmeat was received with an ambient trailer temperature exceeding the critical limit of (b)(4) for approximately 33 hours, reaching (b)(4), without a time/temperature assessment or corrective action. The product was distributed. The firm's March 23, 2018, response was inadequate as it did not include an assessment of affected lots or actions to prevent recurrence. 2. **Inadequate critical limits (21 CFR 123.6(c)(3)):** The HACCP plan's critical limit of (b)(4) for receiving and refrigerated storage of pasteurized canned crabmeat is insufficient to control *C. botulinum* toxin formation. The plan allows product temperature to exceed 70°F for more than the