FDA WARNING_LETTER - Wimberger's Old World Bakery - October 29, 2010

On October 20-29, 2010, the FDA inspected Wimberger's Old World Bakery in Colorado Springs, Colorado, and found serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These conditions render the bakery's bread 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, potentially leading to contamination or rendering them injurious to health.

The primary violation cited was the firm's failure to take effective measures to exclude pests from processing areas and protect food from contamination, as required by 21 CFR 110.35(c). Inspectors observed live and dead flour beetles (including larvae), fruit flies, ants, and flies on/in in-process bread dough, raw ingredient containers, finished bread products, production equipment, and in the oven and production rooms.

While the FDA acknowledged the firm's November 11, 2010, response promising improved cleaning, they recommended evaluating the effectiveness of these corrections and making further facility, equipment, and cleaning process changes to ensure ongoing pest exclusion. The FDA will verify all corrections during the next inspection.

Wimberger's Old World Bakery must take prompt action to correct these violations. Failure to do so may result in legal action, including seizure and/or injunction. The