The laundry list of potential faults during an FDA inspection runs long, but brazen errors tend to get investigators especially riled up. That was certainly the case with Indian drugmaker Vega Life Sciences after company employees allegedly deleted some potentially incriminating testing data.
The FDA blasted Vega's facility in Telangana, India, after investigators identified missing raw testing data on company computers that appeared to have been deleted by staff, according to a warning letter posted online Tuesday.
At the time of the FDA inspection in November, Vega recovered solvents to be reused in manufacturing active pharmaceutical ingredients (API). The company failed to adequately test its products to ensure they met quality standards for production, inspectors found. Vega also didn't perform adequate chromatogram testing on its solvent batches, and the FDA noted "extraneous peaks" in sampled lots that the company couldn't explain away.
Even more troubling for investigators, however, were missing raw data files from solvent recovery testing, the agency said. Investigators identified the missing data sets on a hard drive system, and Vega said the files appeared to have been deleted by staff.
The FDA issued a Form 483 report in December and Vega exited the solvent recovery business after that. In April, the agency put Vega under an import alert, barring its products from entering the U.S.
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The FDA chalked up the data security failures to two things: a commonly shared username and password system that allowed employees to tamper with data and the lack of an audit trail protocol to identify flaws. The company also did not consistently back up its data, leading to the potential for data loss, investigators said.
The agency recommended that Vega hire a data consultant to provide a full accounting of the firm's data flaws and establish quality control protocols for future operations.
In addition to flagging the testing and data flaws, FDA inspectors said Vega's employees did not use adequate cleaning techniques for the facility's equipment. The employees had failed to produce cleaning records while investigators were on site, but later sent those documents to the FDA.
After the FDA issued Vega a Form 483 letter in December, the company told investigators that it had halted its recovered solvent operations. However, the FDA noted that Vega's response also included a reference to including "quality agreements" with future customers, indicating the company could resume those operations in the future.
When the FDA placed Vega on import alert back in April, it required the company to perform corrective measures before its products could be reintroduced stateside.