The United States Food and Drug Administration has recommended that drugmaker Cipla engage a consultant to assist in meeting the current Good Manufacturing Practices ( cGMP) requirements.

The recommendation is part of the USFDA’s warning letter to Cipla, following cGMP violations at its Pithampur plant in Indore (Madhya Pradesh). The regulator has raised multiple issues including data integrity, bacterial contamination, among other things, and this has industry analysts concerned on the possible escalation of the situation to an import alert. Cipla shares were down over 6.5 percent on the development, at ₹1188.20 on the BSE, at 12. 58.

In a stock exchange intimation earlier this week, Cipla had said it was responding to the letter and would comply. It has 15 days to respond.

The USFDA warning letter, dated November 17, 2023 , follows a routine cGMP inspection at the Pithampur manufacturing facility, undertaken between February 6 and 17, 2023, the company had told BSE. The site manufactures inhalers, among other things, and played a crucial role in the launch of its generic Advair in the US. Cipla’s management have in the past indicated, they were derisking the process and transferring the product to another site.

CGMP violations

In it’s letter, the USFDA said, the company had 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. “Your investigations into quality defect complaints of Albuterol Sulfate Inhalation Aerosol were inadequate because they lacked appropriate and timely corrective actions and preventive actions (CAPAs). You also failed to extend your investigations to other potentially affected batches,” it said, adding that the firm received “a very high number of complaints (approximately 3,000) from the start of commercial manufacturing in April 2020 to December 2022.”

In other transgressions that were red-flagged, the regulator said, the company had failed to establish and follow appropriate written 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. The USFDA also pointed to repeat violations from multiple sites, referring to the Goa plant that had been hauled up by the USFDA over issues including, “inadequate equipment cleaning procedures, inadequate investigations of high efficiency particulate air (HEPA) filter integrity test failures...”

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