Natco plant in TG gets USFDA warning
US health regulator finds fault with Natco Pharma for not maintaining cleanliness at Kothur plant in Telangana
image for illustrative purpose
New Delhi: Natco Pharma failed to maintain cleanliness, sterilise equipment and utensils at appropriate intervals at its Telangana-based plant, as per the US health regulator.
In the warning letter to the company, US Food and Drug Administration said its investigators observed various violations at the finished pharmaceuticals plant located at Kothur Village in Telangana. The USFDA inspected the facility from October 9 to 18, 2023.
“Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilise 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,” the US health regulator noted. It further said: “Your cleaning procedure for your non-dedicated equipment is inadequate.”
Cross-contamination is not uniform, and the testing of control samples and placebo batches failed to scientifically prove that products are free of contaminants from visibly dirty equipment, USFDA stated.
“You do not sufficiently address contamination recovered from product contact surfaces, and you fail to acknowledge 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 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. The USFDA sought a comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification (OOS) results, discrepancies, failure, and records management system.
