USFDA 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 (USFDA) also warned the firm that until it corrects all violations, it may withhold approval of new drug applications from the plant.
The USFDA 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 USFDA 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.