In a Bombay Stock Exchange filing, Dr Reddy’s Laboratories announced an audit at its Duvvada, Visakhapatnam facility – in the Indian state of Andhra Pradesh – was completed today and resulted in a Form 483 with 13 observations.
Spokesman Calvin Printer told in-Pharmatechnologist.com the visit by the US Food and Drug Administration (FDA) was a re-inspection after the plant was subject to a warning letter in November 2015.
“Our priority is to respond to the observations as fast as we can,” he told us, though was unable to divulge details of the Agency’s criticisms. “We are still in the process of validating the observations.”
The firm has 15 business days to reply to the FDA.
The Duvvada plant, a finished formulation facility for oncology drugs, was one of three Indian sites hit with the 2015 warning; the other two were active pharmaceutical ingredient (API) facilities in Srikakulam (also in Andhra Pradesh) and Tripuraram (Telangana).
Last month, the Miryalaguda, Tripuraram plant was issued with an FDA Form 483 with three observations, following a re-inspection.
The FDA found significant violations of cGMP at Duvvada. These included malfunction of equipment, an example being an operator repeatedly using forceps to manually assist the transportation of vials along a conveyor belt.
“You did not simulate these critical manual interventions during media fills, so you have no basis to know whether they may compromise the sterility of your products,” the Agency said at the time.
“Even though your senior management was notified of this failure, you did not initiate an incident report to investigate the equipment malfunction or determine the effects of this discrepancy on the quality of the product until we concluded our inspection and issued a Form 483.”
The Agency also cited failures in following written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, and written procedures in production and process controls designed to ensure purity.
“Parenteral drugs must be essentially free of particulates. However, during the inspection, we observed that your procedure for qualifying the operators who perform visual inspection is unacceptable because you did not document the creation of inspectors’ qualification kits.”