FDA WARNING_LETTER - Serpe & Sons Inc - March 06, 2014

The FDA inspected Serpe & Sons, Inc.'s food processing facility from February 27 to March 6, 2014, identifying serious violations of Current Good Manufacturing Practice (cGMP) regulations (21 CFR Part 110). These violations render the food products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations include: 1. **Equipment and Utensil Maintenance:** Cobwebs and dust observed above shortening and Kaiser Roll machinery, and an open flour container on the machine. (21 CFR 110.80(b)(7)) 2. **Raw Material Storage:** Open bags of flour stored under a filthy refrigeration unit, and open bags of sugar, flour, and other dry ingredients near pooling water and covered with filthy plastic. (21 CFR 110.80(a)(1)) 3. **Facility Space:** Racks for bread, cakes, and pastries stored outside the production area, exposed to birds, and moved inside without cleaning. (21 CFR 110.20(b)(1)) 4. **Cleaning Operations:** Visible stains, cobwebs, and a broken fan on the bread proofer near exposed dough. (21 CFR 110.35(a)) 5. **Finished Food