The US health regulator has issued a warning to Cadila Healthcare for violation of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals at its facility in Gujarat.
In a letter posted on the US Food and Drug Administration (USFDA) website, the American health regulator said it identified significant violations of CGMP regulations for finished pharmaceuticals during its inspection of the company's plant at Sanand, in Gujarat.
The USFDA, which inspected the plant between January 17 and February 3, 2011, said it had reviewed the firm's response to its observations on February 10, 2011, and noted that "it lacks 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," it said.
The USFDA cited the example of inability of the company's microbiologists to identify microbial growth correctly.
"We are concerned that trained microbiologists employed by your firm were unable to accurately identify microbial growth on environmental monitoring plates," it said, adding that the corrective measures taken by the firm were inadequate.
The health regulator noted that the firm was responsible for the accuracy and integrity of the data.
When contacted, a company spokesperson said: "We have received a warning letter from the agency based on the pre-approval inspection of our new injectable area. We are addressing the issue expeditiously to resolve the matter. We do not expect any impact on our current business."
The US health regulator has given 15 days to the firm to notify the steps it has taken to correct the violations.
"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 your facility, including any registration lots," the health regulator said.
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.
The company's formulation plant at Moraiya, in Sanand, makes tablets, capsules and soft gel capsules as well as injectable drugs in both sterile liquid and lyophilised form.
Shares of Cadila Healthcare were being quoted at Rs 931.40 apiece in late afternoon trade on the Bombay Stock Exchange today, down 1.82% from their previous close.
