ReConserve Inc. – FDA Warning Letter, Jun 29, 2023

The FDA issued a Warning Letter to Mr. Luskin, owner of an animal food manufacturing facility at 3220 Sun Street, Baltimore, MD, following an inspection from May 23 to June 29, 2023. The inspection, prompted by a complaint about ingredient storage, revealed significant violations of Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals requirements (21 CFR Part 507), rendering products adulterated.

Key violations include: 1. **Failure to examine and protect raw materials (21 CFR 507.25(b)(1)):** Human food bakery by-products for animal food were stored uncovered on gravel outdoors, showing deterioration, foreign material (gravel, soil, mud, unknown substances), and pest activity (birds, insects). The firm resumed using these ingredients without evaluation after a brief cessation. 2. **Inadequate protection of outdoor bulk animal food (21 CFR 507.17(c)):** The uncovered outdoor pile was exposed to contamination from weather, pests, and foreign objects. The firm's claim of sterilization capability was unsupported, and other hazards like nutrient degradation and chemical contamination were not addressed. 3. **Poor grounds maintenance (21 CFR 507.17(a)(1)):** Discarded equipment, trash, and debris were stored against the facility wall