US Drug Regulator Warns Apotex Over Manufacturing Violations at Bangalore Plant

The US Food and Drug Administration (USFDA) 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, the US health regulator 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 FDA 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 was 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 regulator 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," it said .

It further warned that failure to correct these deviations may result in FDA continuing to "refuse admission of articles manufactured at Apotex Pharmachem India Pvt Ltd".

The FDA has given the company 15 working days to notify it of the specific steps that it has taken to correct and prevent the recurrence of deviations, and provide copies of supporting documentation.