US FDA red flags Glenmark over batch failure investigations at Baddi facility

The US health regulator has red flagged Glenmark Pharmaceuticals for failing to thoroughly investigate violation of manufacturing norms and implement corrective action at its Baddi plant in Himachal Pradesh. The United States Food and Drug Administration (US FDA) also warned the firm that until it corrects all violations, it may withhold approval of new drug applications from the plant.

The US FDA had inspected the drug manufacturing facility in Baddi from April 15 to 20, 2019.

“We reviewed your May 10, 2019, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence,” the US FDA said.

In a letter to Glenmark Pharma’s Chairman and MD Glenn Saldanha, the regulator said, “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 the batch has already been distributed.”

The company also failed to ensure that its investigations identify appropriate root causes and failed to implement sustainable corrective action and preventive action (CAPA), it added.

“Your quality system for investigations is inadequate and does not ensure consistent production of safe and effective products,” the letter said.

The US FDA said that in response to the letter, the company should provide a comprehensive, independent assessment of its overall system for investigating deviations, discrepancies, complaints and failures and also furnish a detailed action plan to remediate this system.

It also asked the company to provide an independent assessment and remediation plan for its CAPA program.

Further, the letter asked Glenmark to provide independent review of all its processes to determine their state of control.

The regulator also pointed out that the violations cited in the letter are not intended to be an all-inclusive statement of violations that exist at company’s Baddi facility.

“Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new drug applications or supplements listing your firm as a drug manufacturer,” the letter said. Failure to correct these violations may also result in the FDA refusing admission of articles manufactured at company’s Baddi facility into the US, it added.