OCTOBER 5, 2019
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.
New Delhi: 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.
Another issue flagged by the regulator in the letter to Lupin’s Group President – CEO Vinita D Gupta said: “Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess.”
About the inadequacy for the cleaning process for the manufacturing equipment, the USFDA said: “Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.”
The USFDA also said it has cited similar CGMP violations at two other facilities in the company’s manufacturing network.
“On November 6, 2017, we issued a warning letter to your facilities Lupin Ltd, Goa, and Lupin Ltd, Indore”, the letter said. These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate, it added.
“You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and the products you manufacture conform to FDA requirements,” the letter said.
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,” it added.
The US regulator further said failure to correct these violations may also result in FDA refusing admission of articles manufactured at Lupin Ltd at Unit 1 of the Mandideep facility in the United States.
It also asked Lupin to respond in writing within 15 working days after the receipt of the letter, specifying what it has done since inspection by FDA to correct the violations and to prevent their recurrence.
