M circle M Canning Co. – FDA Warning Letter, Sep 24, 2012

On September 13-24, 2012, the FDA inspected M circle M Canning Company in Seguin, Texas, where acidified foods are manufactured. The inspection revealed serious violations of 21 CFR Part 108 (Emergency Permit Control) and Part 114 (Acidified Foods), rendering products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to file scheduled processes for multiple acidified foods (e.g., candied jalapenos, various relishes, pickles) with the FDA, as required by 21 CFR 108.25(c)(2). Previous attempts in 2009 were returned, and despite a stated intent to resubmit in October 2012, filings were still pending. 2. Failure to establish scheduled processes by a qualified person for products like dill pickles, pickled okra, and corn relish, violating 21 CFR 114.83. The firm acknowledged plans to have products evaluated but had not provided evaluations. 3. Failure to fully reprocess, thermally process as a low-acid food, or set aside for evaluation a portion of food (Farm Fresh Salsa lot A082712) that deviated from its scheduled process, as per 21 CFR 114.89. A discrepancy was noted between