FDA WARNING_LETTER - Orangeburg Pecan Company Inc - November 16, 2017

The FDA inspected a ready-to-eat (RTE) pecan processing facility from October 17 to November 16, 2017, revealing serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117, subpart B).

The inspection and sample analysis (INV1014991) confirmed rodent excreta pellets, leading to the determination that RTE pecan products were adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Violations included: 1. **Pest Exclusion (21 CFR 117.35(c)):** Evidence of insect and rodent activity, including rodent excreta and dead insect parts on/around pecan dryers (food contact surfaces), and live cockroaches. 2. **Hygienic Practices (21 CFR 117.10(b)):** Employees touched shelled pecans with bare hands after touching non-food contact surfaces without washing. 3. **Food-Contact Surface Cleaning (21 CFR 117.35(d)):** Accumulation of dirt, grime, and debris on pecan dryer food contact surfaces and visibly dirty green barrels used for shelled pecans, cleaned only monthly. 4. **Food-Contact Surface Seams (21 CFR 11