The FDA issued Dr. Reddy’s a Form 483 after an inspection of its Medak, Telengana facility in India determined it did not establish quality agreements with material suppliers and failed to complete multiple CAPAs in a timely manner, among other violations.

The investigator of the Indian facility noted that the firm’s quality unit did not close ten CAPAs within the allowable timeframe and did not request an extension of the deadlines.

In addition, the firm neglected to establish quality agreements with some of its starting materials suppliers, including a supplier that provided ingredients used to manufacture product for the U.S. market.