FDA WARNING_LETTER - Dutchman's Bakeshop, LLC - November 12, 2014

On February 3, 2015, the FDA issued a Warning Letter to Dutchman's Bakeshop, LLC, a manufacturer of ready-to-eat ice cream cones, following an inspection from November 3 to November 12, 2014. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering the food adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Specifically, the firm failed to effectively exclude pests from processing areas and protect food from contamination (21 CFR 110.35(c)). Investigators observed numerous insects and rodent excreta pellets in the Production Area, including general work, storage, dishwashing, and ingredient mixing rooms. This issue was previously cited in a July 2013 FDA inspection and by the Virginia Department of Agriculture and Consumer Services (VDACS). The firm voluntarily destroyed approximately (b) (4) of finished product due to insect activity.

Additionally, the firm failed to provide adequate screening against pests (21 CFR 110.20(b)(7)). Gaps were observed around exit doors in the Production Area, Bay #1, and loading dock doors in Bay #3. This deficiency was also cited in the July 2013 FDA inspection and by VDACS.

The FDA requires a written response within fifteen