FDA 483 - Homeocare Laboratories, Inc. - February 21, 2023

Homeocare Laboratories, Inc. in Yonkers, NY, a homeopathic drug manufacturer, was cited for ten significant violations during an FDA inspection from January 30 to February 21, 2023. The observations highlight severe deficiencies in quality control, production and process controls, equipment qualification and maintenance, stability testing, and record-keeping. These issues indicate a systemic failure to adhere to good manufacturing practices, potentially impacting the safety, identity, strength, quality, and purity of their drug products.