Zydus Lifesciences (NSE:ZYDUSLIFE, BOM:532321) said it received a warning letter from the U.S. Food and Drug Administration related to its formulations manufacturing facility in Baddi, Himachal Pradesh, according to a Wednesday filing on Indian bourses.
The warning letter was issued in response to a records request under the Federal Food, Drug, and Cosmetic Act, the company said. It relates to observations regarding the use of purified talc that did not meet current U.S. Pharmacopeia requirements.
Zydus said the letter is not linked to an on-site inspection and does not affect current operations or supplies from the facility.