The US Food and Drug Administration (USFDA) has issued a warning to Cadila Healthcare for violation of current goods manufacturing practice (CGMP) regulations for finished pharmaceuticals at its facility in Gujarat.
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 company, Pankaj Patel, dated June 21, 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 February 10, 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.
According to company officials, the inspection was a pre-approval inspection for the new injectable, hence currently no product was being manufactured at the plant.
"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," a company spokesperson said.
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The regulator expressed concern over the ability of the company's microbiologists, who are said to have failed to identify the microbial growth. "We are concerned that trained microbiologists employed by your firm were unable to accurately identify microbial growth on environmental monitoring plates," it said, adding the corrective measures taken by the firm were inadequate.
According to the regulator, these violations caused company's drug products to be adulterated.
The regulator may also withhold approval to any new application filed by the company. "Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer," the regulator wrote.
"Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation," it said.