FDA Cites Dr. Reddy’s Labs Over Inspection Findings

FDA has cited inspection findings at Dr. Reddy’s Laboratories’ Srikakulam, Andhra Pradesh, India, manufacturing facility, flagging a range of quality-control, testing, and manufacturing deficiencies that could affect drug products shipped to the U.S. market. In a seven-page Form FDA 483 issued 12/12 following an inspection conducted earlier last month, agency investigators documented five major observations at the plant, which manufactures multiple tablet products for the U.S.

FDA’s most extensive concerns centered on the firm’s handling of out-of-specification (OOS) test results. Investigators said the company failed to thoroughly investigate unexplained discrepancies when batches failed dissolution testing and other quality specifications.

In one case, two batches that failed dissolution testing 4/2025 were retested after the company hypothesized — without supporting evidence — that a mispositioned dissolution paddle caused the initial failure. FDA noted that contemporaneous analyst checklists indicated the paddles were correctly placed and tablets fully disintegrated, undermining the firm’s stated root cause. Despite the unresolved discrepancies, the company invalidated the original OOS results and released the batches, which were subsequently shipped to the U.S. market.

FDA described a similar pattern in 1/2025 deviation involving an extraneous peak detected during dissolution testing. After confirming the abnormal result, the firm attributed the issue to a dropper used during sample preparation, retested the batch, and released it without identifying a definitive root cause. The affected product was also distributed in the U.S., according to the agency.

The inspection report further noted that some of the implicated batches were used to manufacture downstream lots that were later shipped to U.S. customers.

FDA also cited the firm for its handling of market complaints, including cases involving incorrect tablet imprints, commingled products, foreign material, and discoloration. Investigators said Dr. Reddy’s dismissed some complaints involving non-recalled batches by assuming mix-ups occurred at pharmacies, without providing supporting evidence to substantiate those conclusions.

Separately, FDA faulted the company for continuing manufacturing operations after replacing a tablet compression machine with a different make and model, without requalifying the equipment. The original machine had broken down during production in 3/2024, and a replacement unit was installed to complete manufacturing of the batch.

As of the December 2025 inspection, FDA said neither the original nor replacement tablet press had been requalified, despite differences in equipment design. Investigators also found that cleaning validation was not re-established after the equipment change, even though the replacement machine had a larger surface area—an issue that could affect residue carryover risks.

Additionally, the FDA 483 also identified deficiencies in laboratory testing practices, including validation of assay methods based on single measurements where procedures required multiple measurements. FDA said these methods were routinely used to release products destined for the U.S. market.