FDA WARNING_LETTER - Carmack Industries LLC - April 23, 2013

The FDA inspected Carmack Industries LLC's acidified food facility in Rathdrum, Idaho, from March 28 to April 23, 2013, revealing serious violations of 21 CFR Part 108 (Emergency Permit Control) and Part 114 (Acidified Foods). This resulted in the determination that their acidified food products are adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Key violations include: 1. **Failure to file scheduled processes:** The firm did not submit scheduled processes for their Taco Chic Salsa (Mild, Medium, Hot, 16 oz. and 32 oz. glass jars) as required by 21 CFR 108.25(c)(2). 2. **Failure to register:** The firm failed to register as a commercial processor of acidified foods with the FDA, violating 21 CFR 108.25(c)(1). 3. **Inadequate recordkeeping:** The firm failed to maintain processing and production records showing adherence to scheduled processes, including pH measurements and critical factors (e.g., holding temperature/time, container inversion time), as required by 21 CFR 114.100(b). 4. **Insufficient quality control:** The firm failed to employ appropriate quality control procedures (21 CFR 114.8