MUMBAI (Reuters) - Shares of Sun Pharmaceutical Industries Ltd
Sun received two so-called Form 483s, issued when the U.S. regulator has queries, for its Detroit-based Caraco Pharmaceutical Laboratories Ltd following inspections in January and May this year, Bloomberg reported on Monday, citing a Freedom of Information Act request.
A Sun Pharma spokeswoman told Reuters in an email that the company "had responded" to the Form 483s "a long time back," and called them "minor observations". She did not provide further details.
Bloomberg reported the FDA inspectors had found temperature control lapses, some improperly sealed containers and a deviation of quality control procedures.
The U.S. FDA could not be immediately reached for comment.
Indian drugmakers have been battered this year by a rash of U.S. regulatory rebukes, and have faced closer FDA scrutiny, reflecting the country's growing importance as a supplier to the United States.
Sun shares ended down 1.2 percent compared to a 0.7 percent fall in the broader Nifty.
(Reporting by Abhishek Vishnoi; Writing by Rafael Nam; Editing by Jeremy Laurence)