quinault tribal enterprise – FDA Warning Letter, May 12, 2011

On April 28, 2011, through May 12, 2011, the FDA inspected Quinault Tribal Enterprise (QTE), a seafood and low-acid canned food manufacturer. The inspection revealed serious deviations from 21 CFR 108, 113, and 110, and 21 CFR 123. The FDA determined QTE's low-acid canned seafood products were adulterated under Section 402(a)(4) of the Act due to insanitary conditions.

Key violations include: 1. Failure to report process deviations of potential health significance to the FDA, specifically severe looseness of double can seams, as required by 21 CFR 108.35(d). 2. Failure to maintain current and complete recall procedures and to follow them, as required by 21 CFR 108.35(f). 3. Failure to perform and record frequent teardown examinations for seam integrity, lacking records for 26 production days and showing identical measurements for extended periods. Laboratory analysis confirmed inadequate hermetic seals and microbial presence in 25 samples, including viable Gram-positive and Gram-negative aerobic and anaerobic microorganisms, Bacillus licheniformis, Rhizobium radiobacter, Pseudomonas aeruginosa, Serratia marcescens, and Staphylococcus sciuri. QTE also lacked on-site can seam teardown equipment. (21