"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," the USFDA said.
The significant violations included the 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. "Your firm manufactures sterile injectables and solid dosage drug products. You failed to conduct adequate out-of-specification (OOS) and complaint investigations, including the identification of the root cause and timely implementation of effective corrective action and preventive action (CAPA) plans," the USFDA noted.
The US health regulator sought a comprehensive, independent assessment of the company's overall system for investigating deviations, discrepancies, complaints, OOS results, and failures.
"Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality assurance unit oversight, and written procedures," it noted.
The USFDA also pointed out the company's failure to follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product including the review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications.
"Because you failed to correct the repeat violation from the previous inspection, we strongly recommend engaging a consultant qualified to evaluate your operations to assist your 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 October 9 and has given the company 15 days to respond.
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