FDA Warns Indian Drug Cos. of Continued Import Alert for CGMP Violations
The Food and Drug Administration warned two Indian drug manufacturers that “serious” violations of current good manufacturing practice requirements could result in the agency continuing to refuse imports made at the two companies’ facilities. In letters dated Jan. 9 and…
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Jan. 30, respectively, FDA listed the violations its inspectors found at Bangalore facilities run by Micro Labs Limited (here) and Apotex (here). FDA requested from each a “comprehensive evaluation” of data inaccuracy at the facilities, a risk assessment, and a management strategy including corrective action.