Pharma manufacturers in India, US latest to receive quality control hits from the FDA
Two drug manufacturers on opposite sides of the globe are facing the heat from the FDA over several quality control issues.
India-based manufacturer Sun Pharma was hit with a Form 483 following an FDA inspection of its Mohali facility from Aug. 3-12.
The FDA found failures when reviewing unexplained discrepancies regarding whether a batch already had been distributed at the location.
The investigation found that there were instances of backdating, but Sun’s report was not thorough enough for the FDA to evaluate the full scope of the offense. Sun did not interview all quality assurance reviewers, but it did confirm backdating by employees who had denied the practice initially. Sun also did not have a thorough review of other work performed by the employees, according to the FDA report.
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