FDA WARNING_LETTER - Meherrin Agricultural & Chemical Co. - December 06, 2011

On November 15 - December 6, 2011, FDA investigators inspected Hampton Farms Industrial Plant in Severn, NC, a peanut butter processing facility. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods (21 CFR Part 110), causing peanut butter products to be adulterated under Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)].

Significant CGMP violations included: 1. **Equipment Design and Use (21 CFR 110.40(a)):** A band saw was used to cut customer-returned peanut butter jars, and the product was reworked into new product post-kill step, exposing it to potential extraneous material and contamination. The firm voluntarily recalled specific lots. 2. **Raw Material and Rework Storage (21 CFR 110.80(a)(5)):** Approximately (b)(4) pound barrels of exposed, leaking peanut butter jars with cut bottoms were stored in the finished product warehouse awaiting rework, contaminating other containers. Additionally, (b)(4) pallets of returned finished product for rework were not labeled or identified. The firm destroyed the embargoed barrels on December 6, 2011. 3. **Plant and Facilities Design (21 CFR 110.20(b)(2)):