FDA 483 - Homeocare Laboratories, Inc. - December 13, 2019

An FDA inspection of Homeocare Laboratories, Inc. in Yonkers, NY, a homeopathic drug manufacturer, revealed significant deficiencies across its operations. The firm lacked adequate written procedures for production and process controls, failed to perform essential product testing and stability assessments, and did not properly validate manufacturing processes or equipment cleaning. Additionally, expired ingredients were used, and raw materials were accepted from unqualified vendors without proper identity testing.