Dr. Reddy’s Hit With 483 for Supplier Quality Agreements, CAPA Issues
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.
The facility also failed to follow complaint handling procedures related to API materials. For example, a complaint required the investigation of a sample provided by the customer which was left unresolved by the firm, and a final investigation report was not issued.
Buildings used in manufacturing, processing and packing of API finished materials were also not maintained. The ceiling above the opening of an area used for production was cracked and in a state of disrepair, and the ceiling above another opening had a large hole in it.
In addition, separate or defined areas meant to prevent contamination were deficient regarding quarantine storage for finished materials. Drums of a finished API batch with quarantine labels were not moved from a packaging room for nearly two months after manufacturing, with no explanation given.
The firm also failed to properly maintain its equipment used for manufacturing, the agency said.