SR Rosati, Inc. – FDA Warning Letter, Jun 6, 2012

On September 7, 2012, the FDA issued a Warning Letter to SR Rosati, Inc. following an inspection from May 30 to June 6, 2012. The inspection revealed significant deviations from Current Good Manufacturing Practice (cGMP) regulations (21 CFR Part 110) and food labeling regulations (21 CFR Part 101), rendering the firm's food products adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.

cGMP violations included: 1. **Facility Construction:** Condensate accumulation and degrading insulation directly above in-process food, and pipe material/dust over uncovered hoppers (21 CFR 110.20(b)(4)). 2. **Sanitation:** Blackish/brownish residue on food-contact buckets, unsanitary spatulas, and pitted dolly floors with liquid accumulation (21 CFR 110.35(d)). 3. **Handwashing Facilities:** Absence of handwashing stations in the bulk and filling rooms (21 CFR 110.37(e)(1)). 4. **Employee Hygiene:** Employees failing to wash hands thoroughly before handling food or after touching contaminated surfaces (21 CFR 110.10(b)(3)). 5. **Hair Restraints:** Employees not effectively wearing hair nets or using appropriate hair restraints (