The US Food and Drug Administration (USFDA) has issued a warning letter to Apotex Research, the Indian arm of Canadian pharmaceutical major Apotex Inc, for violating current good manufacturing practice norms at its Bengaluru-based plant.
In the letter, the USFDA said inspectors during November 6-17, 2017, had found significant deviations from standard manufacturing practices at Apotex Research Pvt Ltd's Bengaluru-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," USFDA said.
The significant violations included company's failure 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 said.
USFDA said the company's investigations into out-of-specification (OOS) laboratory results and manufacturing deviations were insufficient and did not include scientifically-supported conclusions.
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Besides, "Your firm failed to establish appropriate in-process specifications to ensure the quality..Your firm's quality systems are inadequate," it added.
USFDA noted that the company's inspectional history indicates that its quality unit does not fully exercise authority, such as ensuring that appropriate investigations are performed with sound conclusions, identifying root causes, and supporting scientific justification.
"Your firm must provide your quality unit with appropriate authority, sufficient resources, and staff to carry out its responsibilities and consistently ensure drug quality," it said.
Because the company failed to correct repeat violations, USFDA strongly recommends engaging a consultant to assist the firm in meeting CGMP requirements, it added.
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 August 9, and has given the company 15 days to respond. The company could not be reached for comments over the FDA letter.
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