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. – The Hans India