FDA WARNING_LETTER - Desserts by Helen, Inc. - March 13, 2023

The FDA inspected a ready-to-eat (RTE) bakery products facility at 283 Thompson Avenue, Louisville, KY, from February 27 to March 13, 2023, finding serious violations of the CGMP & PC rule (21 CFR Part 117). The RTE bakery products are deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Key violations include: 1. **Inadequate Handwashing (21 CFR 117.10(b)(3)):** Employees handled soiled surfaces and trash, then touched RTE cakes and ingredients without washing/sanitizing hands or changing gloves. The firm's response addressed glove changes and handwashing but not hand sanitization. 2. **Unsanitary Facility Maintenance (21 CFR 117.35(a)):** Observations included a visibly unclean walk-in cooler shelf with mold-like substance, food residue on a plastic pallet, standing brown liquid with debris in a drainage basin, pitted and unclean floors (repeat observation from April 2022), and unclean dishwashing machine interior with food residue in the water (repeat observation). The firm's response did not address drainage or floor repairs. 3. **Infrequent Cleaning of Food Contact Surfaces (21 CFR § 117.35(d)):