FDA WARNING_LETTER - Big Daddy's Creamery LLC - April 27, 2010

The FDA conducted an inspection of an ice cream manufacturing facility in Redmond, Washington, on April 20, 21, and 27, 2010, documenting 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. **Pest Exclusion Failure (21 CFR 110.35(c)):** Observed dead rodents, numerous rodent excreta pellets, dead and live insects (psocids, flies, moths, pavement ants), and bird activity (feather, excreta) in processing and storage areas, including directly above open ice cream mix vats. The firm's response was partially adequate but lacked documentation of corrective actions or improved pest control contracts. 2. **Inadequate Pest Protection (21 CFR 110.20(b)(7)):** Unscreened doors, gaps in plastic curtains, and holes in walls/roof allowed pest entry. The firm's response to some issues was partially adequate but lacked documentation of purchases/installations, and proposed timelines for other corrections were unacceptable. 3. **Improper Plumbing (21 CFR 110.37(b