Mission Mountain Food Enterprise Center – FDA Warning Letter, Jun 17, 2008

On June 11-17, 2008, the FDA inspected a facility in Ronan, Montana, manufacturing an acidified food product, (b)(4). The inspection revealed deviations from the Federal Food, Drug, and Cosmetic Act (the Act) and regulations in 21 CFR Part 108 (Emergency Permit Control) and Part 114 (Acidified Foods), rendering the product adulterated under Section 402(a)(4) of the Act due to insanitary conditions.

Significant violations include: 1. Failure to file a scheduled process for the acidified food (b)(4) with the FDA, as required by 21 CFR 108.25(c)(2). 2. Failure to achieve and maintain a finished equilibrium pH value of 4.2 or lower, as specified by the scheduled process and required by 21 CFR 114.80(a)(1). Firm records showed pH values from 4.8 to 5.8, and FDA samples confirmed average pH values of 5.45 and 5.48. 3. Failure to maintain processing and production records showing adherence to scheduled processes, including pH measurements and other critical factors, as required by 21 CFR 114.100(b). Thirteen production sheets lacked pH records, and eleven of those also lacked final cook temperatures. 4.