FDA WARNING_LETTER - Tonka Seafoods, Inc. - August 17, 2011

The FDA inspected Tonka Seafoods, Inc.'s facility in Petersburg, Alaska, on August 15-17, 2011, and found serious violations of the Domestic Low-Acid Canned Food (LACF) regulation (21 CFR 113) and the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The smoked pink and sockeye salmon in retort pouches were deemed adulterated under Section 402(a)(4) of the Act due to insanitary conditions.

Key violations include: 1. Failure to record detailed inspections and tests of container closures with sufficient frequency, as required by 21 CFR 113.60(a)(3). For example, visual retort pouch closure examinations were not recorded for specific salmon lots, and burst/residual air tests were insufficient. 2. Failure to observe, record, and complete corrective actions for gross closure defects, as required by 21 CFR 113.60(a). Approximately 40 pouches were removed for leakage, but no documentation or investigation occurred. 3. Failure to monitor sanitation conditions and practices with sufficient frequency (21 CFR 123.11(b)). This included: * **Condition and cleanliness of food contact surfaces (21 CFR 123.11(b)(2)):** Heavy residue