FDA WARNING_LETTER - Mid Pac Foods, Inc. - June 20, 2012

The FDA conducted an inspection of Mid Pac Foods, Inc.'s facility in Honolulu, Hawaii, from June 15-20, 2012, and found significant deviations from Acidified Food regulations (21 CFR Part 108 and Part 114), rendering their products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Violations include: 1. Failure to file a scheduled process with FDA for All Purpose Barbeque Sauce (21 CFR 108.25(c)(2)). While a filing was submitted, the response did not detail how recurrence would be prevented. Additionally, filings for Black Bean Sauce, Kau Yuke Sauce, Shoyu Chicken Sauce, and Charisa Sauce lacked supporting challenge studies for their specified process temperatures (21 CFR 114.80(a)(1)). 2. Failure to process Black Bean Sauce in conformity with its filed scheduled process; pH measurements ranged from (b)(4) to (b)(4) while the scheduled maximum equilibrium pH was (b)(4) (21 CFR 108.25(c)(3)(i)). The firm's corrective action of adding citric acid was acknowledged, but the need to ensure equilibrium pH and have a qualified process authority was emphasized. 3. Failure to maintain processing and production records documenting adherence to scheduled processes, specifically