FDA Warns Sun Pharma Over Deleting Trial Data

Thousands of laboratory results at Sun Pharma’s Karkhadi manufacturing plant were improperly deleted, according to an FDA warning letter that blasts the Indian generics firm for failing to ensure that tests conducted at the facility included complete data.

The May 7 warning letter, released Tuesday, stems from a four-day FDA inspection of the plant in November 2013 that resulted in an import alert. Sun Pharma’s initial corrective actions after that inspection have not been adequate, the letter said.

FDA inspectors uncovered a history of “unofficial testing” at the facility, the results of which were then ignored, according to the letter. Only the results of later tests were reported, the FDA said.

“Our inspection found 5,301 deleted chromatograms on a computer used to operate two HLPC instruments in your QC laboratory. Many of these files were “trial” injections of batches,” the letter states. According to the FDA, the records were organized between “trial” and “official” analyses conducted by Sun Pharma.

FDA cited an instance in August 2011, when a batch “was analyzed for unknown impurities and the results were reported to be within specifications,” the letter said. “However, the chromatographic data showed that the ‘trial’ injection data for this batch failed the unknown impurities specification.”

The records presented by Sun Pharma often were incomplete and inadequate, the FDA added, lacking batch and testing sample identification details, some of the test data and even the testing method used.   

In gas chromatography analyses, for example, investigators found a computer system that automatically renames file names in a set when one is deleted, making it appear as if nothing is missing.

In addition, the FDA noted poor labeling practices of raw materials and insufficient measures to make sure employees had the necessary qualifications to perform their job. “You did not train your contract employees in CGMP or in job-specific procedures,” the letter said.

Moreover, it added, “CGMP documents, including procedures and batch records, apparently could not be fully comprehended by many of the contract employees,” employees who “conducted critical CGMP operations for your finished drug products such as visual inspection of filled capsules.”

Sun Pharma should immediately review its GCMP procedures, the letter said. It also calls for the hiring of a third-party auditor who can conduct a thorough review of employees, records and policies.

Sun Pharma acknowledged receiving the warning letter. “We will be responding in detail in due course on all the matters highlighted in the letter. In this process, we have learnt and have resolved to work on further strengthening our systems and controls,” Sun Pharma said in a statement.

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