FDA WARNING_LETTER - BioMylz Pvt. Ltd. - February 09, 2026

On July 13, 2026, the FDA issued a warning letter to BioMylz Pvt. Ltd. following an inspection of its Bengaluru, India, manufacturing facility conducted from February 4 to 9, 2026. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations and the Federal Food, Drug, and Cosmetic Act, leading the FDA to classify the firm"s drug products as adulterated and misbranded. The most severe issues involved pervasive data integrity failures, including the discovery of discarded production records in the trash, the falsification of laboratory data, and the lack of original records to support product releases. Additionally, the company failed to adequately validate its manufacturing and cleaning processes, particularly after scaling up production for the U.S. market. The firm also neglected to perform essential microbiological testing for harmful bacteria in topical products and failed to properly register facilities and list drugs with the FDA. In response, the FDA strongly recommends that BioMylz hire an independent consultant to remediate its quality systems. The company is required to conduct a comprehensive investigation into its data integrity practices, perform a risk assessment on all distributed drugs, and provide a detailed corrective action plan. A formal response addressing these deficiencies must be submitted within 15 working days, or the firm faces potential import refusal and withholding of future drug approvals.