Ahmedabad-based Zydus Cadila, listed as Cadila Healthcare on Indian bourses, has received a warning letter from the US Food and Drug Administration (FDA) over violation of current good manufacturing practice (GMP) regulations for finished pharmaceuticals at its facility in Gujarat.
The injectable drug plant of the group near Ahmedabad has not yet started production, but the FDA issued the warning letter on violations identified at the new plant following a pre-approval inspection. The regulator has given the company 15 days to take corrective measures and report back to it.
In a letter to the chairman of the Zydus Group, Pankaj Patel, dated 21 June, the US regulator said it had identified significant violations of CGMP regulations for finished pharmaceuticals during its inspection of the company's plant at Sanand in Gujarat earlier this year.
It notes that the company's response to its observations on 10 February 2011 lacked sufficient corrective actions. "Your firm's laboratory records fail to include complete data derived from all tests necessary to assure compliance with established specifications and standards," the letter states.
The regulator inspected the plant between 17 January and 3 February 2011.
According to the FDA letter, the violation can make the drug products adulterated. The methods, facilities or controls used for their manufacture, processing, packing or holding do not conform to or are not operated or administered in conformity with GMP.