The US drug regulator has flagged manufacturing lapses at Cipla Ltd.'s manufacturing facility in Pithampur, Madhya Pradesh.
The Food and Drug Administration conducted an inspection of the facility in February, according to an exchange filing. According to the details availabe on the regulator's website, the warning letter highlighted violations of the manufacturing practices regulations for finished pharmaceuticals.
Key Issues Flagged By FDA
The company 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 had already been distributed.
The FDA asked Cipla to provide a comprehensive, independent assessment of the overall system for investigating deviations, discrepancies, complaints, out-of-specification results and failures.
It failed to establish and follow appropriate procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile and that include validation of all aseptic and sterilisation processes.
It failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures.
The FDA found that a truck was loaded with bags of scrap from the unit, and the bags were stored at a central scrapyard intended for shredding. The bags of scrap included numerous torn pieces of printer weigh slips pertaining to drug product packaging and a microbiology laboratory sample label with quality assurance signatures.
The FDA asked the company to provide an assessment of the extent of data integrity deficiencies at the facility and identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion and other deficiencies. Cipla has been asked to describe the operations in the parts of its facility in which it discovered data integrity lapses.
The FDA also pointed out similar issues with the Goa facilities of the company, which are under 'official-action-indicated' status.
The company is in the process of submitting the requisite response to the warning letter within the stipulated timelines and will work closely with the FDA to address the concerns.
Shares of Cipla closed 7.93% lower at Rs 1,170.65 apiece on the NSE compared to a flat Nifty 50.
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