FDA WARNING_LETTER - The Bagel Works Cafe Inc - June 12, 2013

On June 12, 2013, the Kansas Department of Agriculture (KDA), on behalf of the FDA, inspected The Bagel Works Cafe, Inc.'s manufacturing facility. This was a follow-up to May 15-21, 2013 KDA inspections that found significant Current Good Manufacturing Practice (CGMP) violations, leading to a voluntary closure and destruction of approximately (b)(4) lbs. of product.

The June 12, 2013 inspection revealed repeated CGMP violations, causing the food to be adulterated under 21 U.S.C. §342(a)(4). Violations included: * **Pest Exclusion (21 CFR 110.35(c)):** Failure to exclude pests, with live adult and juvenile cockroaches observed in processing areas. * **Protection from Contamination (21 CFR 110.20(b)(2)):** Failure to protect food from contamination, evidenced by dusty fans above uncovered dough in a cooler. * **Sanitary Facilities (21 CFR 110.35(a)):** Failure to maintain sanitary and repaired facilities, including broken gaskets on cooler/proofer doors and dead cockroaches on a prep table. * **Equipment Cleaning (21 CFR 110.80(b)(1)):** Failure to properly clean and