O'Kroft Family Foods d.b.a. Willie B's – FDA Warning Letter, Feb 22, 2012

On February 14-22, 2012, the FDA inspected O’Kroft Family Foods d.b.a. Willie B's in Rockwall, Texas, a manufacturer of acidified foods. 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 Maintain Processing Records (21 CFR 114.100(b)):** The firm did not measure and record critical control measurements like heat treatment or time for at least 79 lots of various acidified foods. Additionally, a scheduled process calling for (b)(4) was not performed. 2. **Inadequate pH Control (21 CFR 114.80(a)(2)):** A homogeneous mixture was not prepared to determine the final equilibrium pH, as recommended by 21 CFR 114.90, to ensure finished equilibrium pH values were no higher than 4.6. 3. **Improper Lot Coding (21 CFR 114.80(b)):** Lot codes did not consistently identify the plant or product, with product identifiers varying for the same product. 4. **Lack of Supervised Operations