Indian pharma giant Dr. Reddy’s is still in hot water with the FDA over its API manufacturing plant in Srikakulam, Andhra Pradesh, which netted the firm yet another Form 483 for serious violations.
The inspection revealed out-of-specification drug batches, inadequate OOS investigations and serious quality unit lapses, among other deficiencies.
For example, the agency found a subpar cleaning validation report and a lack of raw data for cleaning validations. “Because there is no raw data, there is no evidence that swab samples were actually analyzed,” the investigators said.
The Srikakulam plant previously received a Form 483 following an inspection by the agency and the facility was one of three Dr. Reddy’s facilities cited in a warning letter.