The FDA slapped Aurobindo Pharma, an Indian drugmaker, with a warning letter for failing to adequately investigate batch failures of active pharmaceutical ingredients and not evaluating the possible effect of changes on the intermediates and APIs manufactured at the site.
The warning letter posted on the regulatory agency’s website comes in the wake of an inspection conducted last August at Aurobindo’s Telangana, Hyderabad, facility.
According to the agency, Aurobindo was cited for “significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients.”
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The company, which has been under FDA scrutiny before, failed to evaluate the effect of changes on the quality of APIs and drug intermediates. The agency said Aurobindo increased its acceptance of limits for starting materials without evaluating the effect of the increase on the quality of intermediates and APIs.
Aurobindo was also cited for failing to “fully” investigate discrepancies uncovered by test results, and some failing results were invalidated “without a scientific rationale.”
Regulators said similar violations were discussed with company representatives during a meeting in late July 2019 and that “repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”
The FDA said in the warning letter it may “withhold approval of new applications or supplements listing your drug as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP.”
Regulatory issues have been a problem with Aurobindo for more than a decade. Back in 2011, the company was hit with a warning letter from the FDA for its packaging and labeling processes.