USFDA warns Apotex over CGMP violations

Updated - November 16, 2021 08:22 pm IST

Published - June 18, 2014 11:39 pm IST - NEW DELHI:

The U.S. health regulator has issued a warning letter to Canada headquartered Apotex Pharmachem over violations of manufacturing norms at its Bangalore plant.

In a letter to Apotex Inc President and Chief Operating Officer Jeremy B. Desai, United States Food and Drug Administration (USFDA) said that its investigators identified ‘significant deviations’ from current good manufacturing practise (CGMP) for the manufacture of active pharmaceutical ingredients (APIs) in the company’s Bangalore plant.

Among the major violations cited by the USFDA was the “failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards” by the company.

The health regulator said accurate raw laboratory data records for API (active pharmaceutical ingredients) batches shipped by Apotex were not maintained.

“The failure to create and maintain accurate documentation is a repeat observation reported to your facility during the 2006 and 2010 inspections,” the USFDA said.

It asked the company to provide a list of all the batches of APIs in distribution and those intended to be shipped to the US market that relied upon “missing, inaccurate, or unreliable test data“.

“Until all corrections have been completed and FDA has confirmed corrections of the deviations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as an API manufacturer,” the regulator said in the letter issued on June 16.

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