FDA 483 - Homeocare Laboratories, Inc. - March 20, 2024

From February 12 to March 20, 2024, the FDA conducted an inspection of Homeocare Laboratories, Inc., a drug manufacturer in Yonkers, NY, resulting in a Form FDA 483 with twelve observations. The agency noted significant deficiencies in the company's adherence to current Good Manufacturing Practices (cGMP). Repeated observations from a 2023 inspection highlighted failures in establishing adequate written procedures for production and process controls, particularly concerning manufacturing process validation for various homeopathic drug products. Equipment and utensils were not consistently cleaned, with residues found and cleaning logs incomplete, indicating potential contamination risks. Critical equipment qualification, including mixers and the manufacturing water system design, was also deemed inadequate.

Further issues included poor facility maintenance, such as heavy dust buildup and staining in production areas, and dislodged ceiling tiles. Laboratory controls were criticized for unverified microbiological test methods, a lack of Total Organic Carbon testing for the water system, and failures to conduct Out-of-Specification investigations for contaminated water and non-conforming raw materials. Personnel were observed not adhering to protective apparel protocols. Additionally, batch and master production records lacked complete manufacturing and control information, and the vendor qualification program for component suppliers was deficient. Homeocare Laboratories, Inc. must promptly address these observations to ensure the quality, purity, and safety of its drug products in compliance with FDA regulations.