FDA 483 - Puremedy Inc. - February 12, 2024

An FDA inspection of Puremedy Inc., a topical homeopathic drug manufacturer in Westlake Village, CA, revealed significant deficiencies across its quality system, production, and laboratory controls. The firm lacked essential written procedures for quality control, process validation, and raw material identity testing. Furthermore, finished product testing relied on subjective sensory methods, and no stability assessments were documented for its homeopathic drug products.