Natco plant in TG gets USFDA warning

New Delhi: According to the US health authority, Natco Pharma failed to maintain hygiene at its Telangana plant and sterilize equipment and utensils at appropriate intervals.

In the warning letter to the company, the US Food and Drug Administration said its investigators observed several violations at the completed pharmaceutical factory at Kothur Village in Telangana. The USFDA inspected the facility from October 9 to 18, 2023.

“Your company has failed to clean, maintain and, as appropriate to the nature of the drug, disinfect and/or sterilize equipment and utensils at appropriate intervals to prevent malfunction or contamination that could affect safety, would alter the identity, potency, quality or purity of the medicinal product beyond official or other established requirements,” the US health regulator noted. It continued: “Your cleaning procedure for your non-specific equipment is inadequate.”

Cross-contamination is not uniform, and testing of control samples and placebo batches could not scientifically prove that products are free of contaminants from visibly contaminated equipment, the USFDA said.

“You are not adequately addressing the contamination found on product contact surfaces, and you are not recognizing that other locations and other sampling may reveal high levels of contamination,” it added.

The US health regulator further stated that the company failed to thoroughly investigate any discrepancies or failure of a batch or any of its components to meet specifications, regardless of whether or not the batch has already been distributed. The USFDA sought a comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification results, discrepancies, errors, and records management system.