American health regulator US Food and Drug Administration (USFDA) has issued a warning letter to Emcure Pharmaceuticals for violating current good manufacturing practice norms at its Pune-based plant. In the letter, the USFDA said inspectors during February 11-20 this year found significant deviations from standard manufacturing practices at company’s Hinjawadi-based plant.
“This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals…because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated,” it said.
The significant violations included failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, the health watchdog added.
“Your review of environmental data was insufficient in that it relied too heavily on findings in the laboratory,” it noted.
The company concluded that data indicated potential contamination control risks in the testing facility, but did not sufficiently address production failure modes, it added.
“Specifically, your investigation failed to thoroughly address container-closure integrity hazards, including but not limited to robustness of the vial sealing process,” the USFDA said.
The US health regulator said it had cited similar kind of observations after an inspection of the facility in 2017.
“Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” the regulator noted.
The company should comprehensively assess its manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured conform with CGMP requirements, it added.
Because the company failed to correct repeat violations, the USFDA strongly recommends engaging a consultant to assist the firm in meeting CGMP requirements, it 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, it added.
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, the regulator added.
The FDA issued the letter on August 2, and has given the company 15 days to respond. The company could not be reached immediately for comments over the FDA letter.