Institute of Good Manufacturing Practices India®

Mandideep facility of Lupin red-flagged by USFDA for CGMP violations


Lupin, a pharma firm was red flagged by the US health regulator for significant violations of the current good manufacturing practice regulations at its Mandideep facility in Madhya Pradesh.

A warning letter was issued by USFDA pointing out the violations including inadequacy of the cleaning process for manufacturing equipment; failure in thoroughly investigating any unexplained discrepancy of a batch or its components; failure in establishing adequate documentation for production and process control designing for assuring that the drug products that are manufactured have the identity, strength, quality, and purity they purport or are represented to possess.

Until all the corrections have been made for the violations mentioned in the letter, till then FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.

The US regulator further added that the failure in correction of 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.

The time period allotted to Lupin for responding to the warning letter issued is 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.