FDA 483 - Uriel Pharmacy, Inc - March 04, 2025

Uriel Pharmacy, Inc., a homeopathic drug manufacturer in East Troy, WI, was cited with 14 observations during an FDA inspection. The firm exhibited significant deficiencies across its quality system, including inadequate component testing, process validations, equipment qualifications, stability studies, and microbiological controls. Additionally, issues were noted in deviation investigations, batch record documentation, labeling controls, complaint handling, cleaning procedures, GMP training, and annual product reviews, indicating a broad lack of adherence to cGMP requirements.