USFDA red flags Lupin for significant violations at MP unit
The US health regulator has red flagged pharma firm Lupin for significant violations of the current good manufacturing practice regulations at its Mandideep facility in Madhya Pradesh. The violations pointed out in a warning letter by the United States Food and Drug Administration (USFDA) include inadequacy of the cleaning process for manufacturing equipment.
Highlighting other lapses, 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 or not the batch has already been distributed."
The USFDA said it had inspected the Unit 1 at the Mandideep facility of the company from November 26 to December 4, 2018, and it had reviewed the December 26, 2018, response of the company in detail and acknowledge receipt of subsequent correspondence.