FDA WARNING_LETTER - Ozark Bottling Co - February 08, 2011

On January 26-February 8, 2011, the FDA inspected Ozark Bottling Co. in Lake Ozark, Missouri, and found serious deviations from Acidified Food regulations (21 CFR Part 108 and Part 114). The company manufactures several acidified food products, including various salsas and a "Hot Veggie Mix." These deviations render the products adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations include: 1. **Failure to file scheduled processes:** The company did not provide the FDA with scheduled processes for seven acidified food products prior to packing, as required by 21 CFR 108.25(c)(2). Although filings were submitted post-inspection, they were returned due to deficiencies. 2. **Inadequate processing and production records:** The firm failed to maintain records demonstrating adherence to scheduled processes, including pH measurements and critical factors (21 CFR 114.100(b)). Examples include missing final pH records and thermal process evidence for "Hot Veggie Mix," and lack of finished equilibrium pH measurements for "Black Angus Salsa." pH meter calibration records were also inconsistent. 3. **Insufficient information in production records:** Records lacked essential details like product code, container size, and lot size/code, hindering