International Fish Canners (Scotland) Ltd. – FDA Warning Letter, Oct 8, 2010

On October 7 and 8, 2010, an FDA inspection of International Fish Canners (Scotland) Ltd.'s canned seafood facility revealed serious violations of the U.S. Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation (21 CFR Part 123). These violations render the firm's canned sardines adulterated under Section 402(a)(4) of the U.S. Federal Food, Drug and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan for Scombrotoxin (Histamine) Formation:** The "Canned Sardines" HACCP plan lists only "receiving" as a critical control point for scombrotoxin, failing to account for multiple pre-canning steps (holding chill, factory chill, thawing, head cutting, grading, brining, hand packing) that may cause time and temperature abuse leading to histamine development. 2. **Improper Grouping of Products:** The same HACCP plan is used for both fresh and frozen sardines, despite differing hazards and control requirements. 3. **Inadequate Histamine Testing at Receiving (Primary Processor):** The firm's histamine testing strategy for fresh fish is insufficient. The critical limit of "(b)(4)" is inadequate, the sample size of "(b)(4)" is not representative (FDA recommends 18 fish minimum), and the test is not quantitative. The plan also