FDA WARNING_LETTER - Pacific Seafood Products, Inc. - March 05, 2008

The FDA inspected Pacific Seafood Products, Inc., a seafood importer, on March 4-5, 2008, and identified serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. As an importer, the firm must ensure all imported fish and fishery products comply with Part 123, otherwise, they are considered adulterated under Section 402(a)(4) of the Act. The inspection revealed three significant deficiencies. First, the firm's affirmative step for imported fresh mahi mahi was inadequate, as they lacked the foreign firm's HACCP plan in English, violating 21 CFR 123.12(a)(2)(ii). Second, the firm failed to maintain product specifications for fresh mahi mahi, contrary to 21 CFR 123.12(a)(2)(i). Third, Pacific Seafood Products had neither developed nor maintained written importer verification procedures for imported seafood products, as required by 21 CFR 123.12(a)(2). These failures render their fresh mahi mahi adulterated. The FDA warns of potential further actions, including refusal of admission, detention without physical examination, product seizure, or injunction. The firm must respond in writing within fifteen working days, detailing specific corrective actions and providing supporting documentation, such as HACCP and importer verification records.