U.S. FDA issues warning letter to Zydus Lifesciences’ Baddi formulation unit
The U.S. FDA has issued a warning letter to Zydus Lifesciences regarding its Baddi formulation unit. The letter highlights issues related to the use of purified talc that did not meet USP requirements. Zydus believes that this warning will not affect its current operations or supplies from the facility.
- ▪The warning letter was issued due to technical observations about purified talc.
- ▪It does not relate to any onsite inspection by the U.S. FDA.
- ▪The last inspection of the facility occurred in August 2025, with a VAI compliance status.
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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.
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Excerpt limited to ~120 words for fair-use compliance. The full article is at The Hindu.
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