Zydus Lifesciences Limited has received a Warning Letter from the United States Food and Drug Administration (USFDA) concerning its formulation manufacturing facility in Baddi, Himachal Pradesh. The letter was issued in response to a request for records under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act, and not due to an on-site inspection. It references technical observations regarding the use of purified talc that did not meet current United States Pharmacopeia (USP) requirements. The company stated that this Warning Letter is not expected to impact current operations or supplies from the Baddi site. The facility was last inspected by the USFDA in August 2025, and the Establishment Inspection Report (EIR) received in October 2025 classified the final compliance status as Voluntary Action Indicated (VAI). Zydus Lifesciences is committed to collaborating with the USFDA to complete necessary remediation steps promptly and respond within the stipulated timelines.
