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."
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."