B A Howie Inc. – FDA Warning Letter, Aug 11, 2011

The FDA inspected B A Howie Inc.'s pickle manufacturing facility in Franklinville, NJ, from August 8-11, 2011, revealing serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These conditions render the pickles adulterated under 21 U.S.C. § 342(a)(4) due to insanitary preparation, packing, or holding.

Violations include: 1. **Failure to prevent contamination (21 CFR 110.80):** Degraded gaskets with "contact cement" on pickling barrel lids, worn/splintered wooden surfaces in cucumber filling equipment, and a splintered wooden plank above brine tanks posed contamination risks. 2. **Improper storage of toxic materials (21 CFR 110.35(b)(2)):** Paint thinner and contact cement were stored near bagged/boxed dry raw ingredients. 3. **Inadequate handwashing facilities (21 CFR 110.37(e)):** Lacked running water at a suitable temperature and sanitary towels/drying devices. 4. **Failure to maintain sanitary facilities (21 CFR 110.35(a)):** Pooling liquid and mud were observed on the cooler floor, posing contamination risks during product processing and storage. 5. **Inadequate drainage (21 CFR