Cadila Healthcare receives USFDA warning for manufacturing violations

06 Jul 2011 Evaluate

Cadila Healthcare has received a warning notice from the US health regulator for violation of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals at its facility in Gujarat. The Gujarat Plant was inspected by USFDA between January 17 and February 3, 2011, and reviewed the firm's response to its observations on February 10, 2011, and noted that it lacks sufficient corrective actions.

The company’s laboratory records fail to include complete data derived from all tests necessary to assure compliance with established specifications and standards. The USFDA cited the example of inability of the company's microbiologists to identify microbial growth correctly. The health regulator noted that the firm was responsible for the accuracy and integrity of the data.

The US health regulator has given 15 days to the firm to notify the steps it has taken to correct the violations and ask to provide a more comprehensive corrective action plan to ensure the integrity of all data used to assess the quality and purity of all drugs manufactured at the facility, including any registration lots.

The USFDA also warned that it could withhold approval of any new applications of the firm until all corrections have been completed and it has confirmed corrections of the violations. It also said failure to correct these violations may result in the FDA refusing admission of articles manufactured at the Sanand facility into the US.

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