Mumbai, July 6: Cadila Healthcare Ltd has received a warning letter from the US Food and Drug Administration (USFDA) for violating current good manufacturing practices (CGMP) regulations at its new injectibles facility in Gujarat.
The US health regulator has issued a warning to Cadila Healthcare for the violation of CGMP regulations for finished pharmaceuticals at its facility in Gujarat. It has now given Cadila Healthcare 15 days to notify its office of the specific steps taken by the firm to correct the violations.
According to the US drug regulator, it had identified significant violations of CGMP regulations for finished pharmaceuticals during its inspection of the companys plant at Sanand in Gujarat.
The USFDA, which inspected the plant between January 17 and February 3, said it had reviewed the firms response to its observations on February 10, and noted that it lacked sufficient corrective actions. Your firms laboratory records fail to include complete data derived from all tests necessary to assure compliance with established specifications and standards, it said. The USFDA cited the example of inability of the companys microbiologists to identify microbial growth correctly.
Meanwhile, the USFDA has imposed an import ban on products made at Dr Reddys Laboratories Mexican plant for violation of CGMP regulations.