Aurobindo Pharma in trouble for manufacturing lapses at API plant
The USFDA pointed at failure of the company's quality unit to ensure that critical deviations are investigated and resolved.;
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New Delhi: The US Food and Drug Administration (USFDA) has issued a warning letter to Aurobindo Pharma for violating current good manufacturing practice norms at its Telangana-based plant.
In a letter to company's Managing Director Narayanan Govindarajan, the US health regulator noted that its inspectors during an inspection between August 2-12, 2021, found significant deviations from standard manufacturing practices for active pharmaceutical ingredients (API) at the company's Doultabad-based plant.
The significant violations included failure to evaluate the potential effect that changes may have on the quality of intermediates and API, the USFDA stated.
The US health regulator said the Hyderabad-based drug firm failed to fully evaluate whether increasing acceptable starting material would impact the quality of the API.
The USFDA also pointed at failure of the company's quality unit to ensure that critical deviations are investigated and resolved.
The USFDA asked the firm to correct the deviations promptly.
"FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations," it noted.
The company's failure to correct these violations may result in FDA continuing to refuse admission of articles manufactured at the plant into the US, it stated.
The FDA issued the letter on January 12, 2022 and has given the company 15 days to respond.
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