The US Food and Drug Administration (USFDA) has issued a warning letter to Ahmedabad-based Cadila Pharmaceuticals for violating current good manufacturing practice norms at its Ankleshwar plant in Gujarat.
In a warning letter, USFDA said inspectors in March had found significant deviations from standard manufacturing practices at Cadila Pharmaceuticals’ Ankleshwar plant, which manufactures active pharmaceutical ingredients.
The significant violations included the failure of the company to adequately probe or take corrective action after customer complaints between 2011 and 2012 about unpleasant odours from, and impurities in, certain drug batches sold in the US, the USFDA said.
The company did not have proper controls in place to prevent the unauthorised manipulation of its electronic raw data, it added.
“Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as an API manufacturer,” USFDA said.
In addition, the company’s failure to correct these violations may result in FDA refusing admission of articles manufactured at Cadila Pharmaceuticals’ Ankleshwar plant into the US, it added.
The FDA issued the letter on October 15, and has given the company 15 days to respond.
The company could not be reached for comments over the FDA letter.