FDA 483 - Homeocare Laboratories, Inc. - June 04, 2021

Homeocare Laboratories, Inc. received a Form 483 citing significant deficiencies across its manufacturing operations for homeopathic drug products. Key issues include a lack of validated manufacturing processes, inadequate stability assessments, unvalidated cleaning and analytical methods, and failures in quality control procedures leading to premature product release. The inspection also identified deficiencies in equipment maintenance, ongoing GMP training, and material storage and segregation.