Two Dr. Reddy’s Plants Hit With 483s in India
July 13th, 2024 // 1:05 pm @ jmpickett
FDA recently handed 483s to two Dr. Reddy’s plants in India. After an FDA audit between May 30 and June 7, Dr. Reddy’s API facility in Pydibhimavaram, India was cited for four FDA 483 observations that were focused on the plant’s cGMP policies.
FDA stated several OOS incidents didn’t have sufficient testing and follow-up after a dozen API batches were produced. In one FDA observation, Dr. Reddy’s was cited for not ensuring that a manufacturing process was maintained in a validated state. The FDAer stated that API that is supposed to be sent to the US for marketed products were released by the QC unit without completing all of the necessary release tests before they were distributed.
In another case, the company was hit with a 483 in May 2024, according to a regulatory brief filed by the firm that was posted on the stock exchange in Bombay. In that case, Dr. Reddy’s said that the formulation manufacturing facilities in Duvvada, India received two FDA citations after a May 2024 inspection. FDA said that the company didn’t offer details of the FDA 483 observations.
