FDA WARNING_LETTER - Backwoods Food Mfg Co Inc - March 26, 2015

On March 24-26, 2015, the FDA inspected Backwoods Manufacturing, Inc., an acidified food manufacturer, and found serious violations of 21 CFR Part 108 and Part 114, rendering products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to control finished equilibrium pH (21 CFR 114.80(a)(2)):** Production records for Black Bean and Corn Salsa and Avocado Salsa Verde lacked documented finished equilibrium pH values for multiple batches/lots. The firm's proposed corrective action lacked supporting evidence. 2. **Inadequate production and processing records (21 CFR 114.100(b)):** Records for Avocado Salsa Verde did not document pH measurements, heat treatment times/temperatures, or fill temperatures. The proposed Hot Fill Production Report was unclear on the type of pH measured. 3. **Lack of a written recall procedure (21 CFR 108.25(e)):** The firm failed to prepare a written recall procedure, though they stated one was being created. 4. **Improper instrument maintenance (21 CFR 110.40(f)):** pH meter calibration was not documented, thermometer accuracy checks were not documented, and expired buffer solutions were used for pH meter calibration