US FDA Issues Warning Letter to Sun Pharma's Dadra Unit Over Repeat Observations

Last month, Sun Pharma's Dadra unit received a warning letter from the United States Food and Drug Administration (USFDA). CNBC-TV has now obtained this warning letter, which outlines several repeat observations, resulting in stringent regulatory action.

Sun Pharma share price have been relatively stagnant over the past three months, declining by more than 6%. 

The warning letter highlighted repeated violations, including insufficient oversight and control over drug manufacturing. Additionally, it indicated that the drugmaker does not maintain an effective quality system.

The warning letter also stated that the company failed to clean, maintain, and sanitize equipment at appropriate intervals and did not investigate unexplained discrepancies in a batch or its components.

The US drug regulator inspected Sun Pharma's Dadra unit from December 4-15 last year, subsequently classifying the facility as 'Official Action Indicated.'

The US FDA designates a facility as OAI (Official Action Indicated) when it identifies serious compliance issues that, if unresolved, could result in export, regulatory, or administrative restrictions. This has been the case for Sun Pharma, as the drugmaker failed to address the observations noted by the US FDA, leading to the issuance of the warning letter.

In an 18 June warning letter posted on Tuesday, the FDA cited Sun Pharma for GMP (Good Manufacturing Practice) issues discovered at its Dadra site in Dadra and Nagar Haveli and Daman and Diu during a mid-December 2023 inspection.

Investigators observed that the firm "failed to adequately clean and maintain equipment used for drug product manufacturing." Specifically, they found 450 mL of an unspecified "stagnant liquid" within a non-dedicated piece of equipment used to produce multiple drug products. A chemical analysis of this liquid using liquid chromatography-mass spectrometry (LC/MS) revealed "numerous peaks," and a microbiological analysis identified "too numerous to count" (TNTC) results for yeast and mold.

The firm also conducted out-of-specification (OOS) investigations that "lacked scientific rationale for root cause determinations." For instance, during an OOS investigation for an unknown impurity detected in a 12-month stability sample of tablets, the results exceeded specifications. Initially, the firm attributed the issue to "dirty glassware." Upon reopening the investigation, the company determined that the root cause was contamination from another product.

The FDA stated that "significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production and laboratory operations, we found your QU [Quality Unit] is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.”

The FDA recommended that the firm hire a GMP consultant and gave it 15 days to respond to the warning letter. The agency instructed the firm to promptly correct these violations or risk having the approval of new applications or supplements withheld.