FDA WARNING_LETTER - Porky's Gourmet Foods, Inc. - December 02, 2014

On November 20, 21, 25, and December 2, 2014, FDA investigators inspected Porky's Gourmet Foods, Inc.'s sauce and dry spice blend manufacturing facility in Gallatin, Tennessee. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations (21 CFR 110), rendering their food products adulterated under Section 402(a)(4) of the Act [21 USC 342(a)(4)] due to insanitary conditions.

Violations included: 1. **Pest Exclusion (21 CFR 110.35(c)):** Apparent rodent excreta pellets and insects were found in production and warehouse areas, including near ingredients. 2. **Pest Protection (21 CFR 110.20(b)(7)):** Unscreened openings and gaps large enough for pest ingress were observed in floor drains, dock doors, walls, and ceilings. 3. **Food-Contact Surface Cleaning (21 CFR 110.35(d)):** Spice filler transfer tubes and metal ends appeared soiled and discolored with adhering spice. 4. **Equipment Installation and Maintenance (21 CFR 110.40(a)):** Bottle loading turntable bumpers were soiled and not easily cleanable; a food-grade hose was damaged with protruding rusty wires