FDA WARNING_LETTER - Healwell Homeo Private Limited - December 20, 2024

On June 12, 2025, the FDA issued a Warning Letter to Healwell Homeo Private Limited following an inspection from December 13-20, 2024. The FDA found the company's drug products adulterated under section 501(a)(2)(A) of the FD&C Act due to insanitary conditions, including live rodents and birds, extensive excreta, mold-like material, insects, stray dogs near entryways, and outdoor storage of manufacturing materials in dirty drums.

Additionally, the products were adulterated under section 501(a)(2)(B) for significant Current Good Manufacturing Practice (CGMP) violations (21 CFR parts 210 and 211). The firm failed to conduct identity testing for drug components, including a mislabeled component, and did not validate supplier test analyses (21 CFR 211.84(d)(1) and 211.84(d)(2)). The quality control unit failed to ensure CGMP compliance and product specifications (21 CFR 211.22), lacking written procedures for complaints, deviations, investigations, cleaning, training, and labeling. They also lacked adequate validation of production controls, equipment qualification, proper batch records, written test methods, and cleaning validation (21 CFR 211.100(a), 211.188