Sunrise Donuts, LLC – FDA Warning Letter, Jun 27, 2013

On August 9, 2013, the FDA issued a Warning Letter to Sunrise Donuts, LLC, following an inspection from June 13-27, 2013, which revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These violations render the manufactured foods adulterated under section 402(a)(4) of the FD&C Act, as they were prepared, packed, or held under insanitary conditions. No written response to the FDA-483, issued on June 27, 2013, was received.

Key violations include: 1. **Equipment and Utensil Sanitation (21 CFR 110.80(b)(1)):** Scrapers and spatulas were stored in soiled water, and mixing bowls/paddles had dry product residue. 2. **Equipment Protection from Contamination (21 CFR 110.80(b)(7)):** Plastic bins and mixing vat paddles were stored on a soiled floor. 3. **Work-in-Process Protection (21 CFR 110.80(b)(5)):** Yeast bags were observed inside a mixing bowl with donut dough, in direct contact with dry ingredients. 4. **Pest Exclusion (21 CFR 110.35(c)):** The shipping