The U.S. Food and Drug Administration (U.S. FDA) has issued a warning letter to Zydus Lifesciences relating to the company’s formulation manufacturing facility in Baddi, Himachal Pradesh.“The communication references technical observations regarding the use of purified talc that did not meet the current United States Pharmacopeia (USP) requirements,” the company said in a filing on Wednesday.The warning letter “does not pertain to any onsite inspection of the facility by the U.S. FDA.” It was issued in response to request for records under a Section of the Federal Food, Drug and Cosmetic Act. The company believes that the warning letter will not impact current operations and supplies from the Baddi site, Zydus said.The manufacturing facility was last subjected to an on-site inspection by the U.S. FDA in August 2025. Subsequent to the conclusion of the inspection, the company received the establishment inspection report (EIR) in October 2025, with the final compliance status classified as Voluntary Action Indicated (VAI). Published - June 03, 2026 09:17 pm IST
U.S. FDA issues warning letter to Zydus Lifesciences’ Baddi formulation unit
The U.S. Food and Drug Administration (U.S. FDA) has issued a warning letter to Zydus Lifesciences relating to the company’s formulation manufacturing facility in Baddi, Himachal Pradesh.
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