The US health regulator has found a significant violation of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals at Cadila Healthcare's Moraiya (Ahmedabad) based manufacturing facility.
In a warning letter issued to the company's Chairman Pankaj R Patel, the US Food and Drug Administration pointed out various deficiencies at the plant, including inadequate cleaning procedure for non-dedicated equipment.
"Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilise equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety identity, strength, quality, or purity of the drug product beyond the official or other established requirements," the US health regulator said in the letter.
The USFDA officials, who inspected the plant from April 22 to May 3, 2019, said the significant equipment flaws and cleaning deficiencies resulted in cross-contamination between the drug products.
The US health regulator also pointed towards the failure of the company to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications.
The US health regulator did not approve of the resolutions brought in by the drugmaker at the facility, terming the steps as inadequate.
"Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes," it further noted.
Besides, the company failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas, it added.
"In previous warning letters, the FDA cited similar CGMP violations. You proposed specific remediation for these violations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate," the USFDA said.
Until all corrections have been completed and FDA has confirmed corrections of the violations and the firm's compliance with CGMP, FDA may withhold approval of any new applications or supplements, the USFDA said.
In addition, the company's failure to correct these violations may result in FDA continuing to refuse admission of articles manufactured at the plant into the US, it added.
The FDA issued the letter on October 29, and has given the company 15 days to respond.
