New Delhi : The US health regulator has issued a warning letter to drug firm Mylan for violations of good manufacturing norms, including data integrity lapses and failure of quality control at its Nashik facility.
The letter by the United States Food and Drug Administration (USFDA) to the Mylan Pharmaceuticals Inc President Rajiv Malik states that it had inspected the Nashik facility of the company from September 5 to 14, 2016.
There were “significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals”, at the facility, it added.
During the inspection, the FDA investigator observed specific violations such as the quality system not fully ensuring data integrity, the regulator said.
“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness and quality of the drugs you manufacture,” the letter said.
While acknowledging that company is using a consultant to audit the operation and assist in meeting FDA requirements the USFDA asked to provide “a comprehensive investigation into the extent of the inaccuracies in data records and reporting”.
The letter also asked the drug firm to provide a current risk assessment of the potential effects of the observed failures on the quality of the drugs and a management strategy “that includes the details of your global corrective action and preventive action plan”.
The FDA said it has reviewed company’s October 5, 2016, response in detail and also acknowledged receipt of its subsequent correspondence.
Other violation was that, “Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed”, the letter said.
The pharma firm also failed to establish an adequate quality control unit with the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated, it added.
“Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer,” the warning letter said.
Failure to correct these violations may also result in FDA refusing admission of articles manufactured at Mylan Laboratories at the Nashik plant, it added.