USFDA warns Natco Pharma for manufacturing lapses at Telangana facility

22 Apr 2024 , 01:41 PM

According to the US health regulator, Natco Pharma failed to keep its Telangana-based factory clean and disinfect equipment and utensils at regular intervals. In its warning letter to the corporation, the US Food and Drug Administration stated that its investigators discovered many infractions at the finished pharmaceuticals factory in Kothur Village, Telangana.

From October 9 to 18, 2023, the US Food and Drug Administration inspected the plant.

The US health regulator pointed out that the company neglected to adequately clean, maintain, and, when necessary for the type of drug, sanitize and/or sterilize equipment and utensils at suitable intervals. This failure could lead to malfunctions or contamination, potentially compromising the safety, identity, strength, quality, or purity of the drug product beyond the official or other established standards.

Additionally, the USFDA stated that the company’s cleaning procedure for non-dedicated equipment is insufficient. They highlighted that cross-contamination is not consistently addressed, and the testing of control samples and placebo batches failed to scientifically demonstrate that products are devoid of contaminants originating from visibly dirty equipment.

The US health agency also claimed that the corporation failed to adequately investigate any discrepancy or failure of a batch or any of its components to satisfy any of its criteria, regardless of whether the batch had already been delivered.

The USFDA requested a thorough, independent evaluation of Natco’s entire system for examining deviations, inconsistencies, complaints, out-of-spec (OOS) findings, discrepancies, failures, and records management.

The USFDA also noted the company’s commitment to temporarily halt the production of all drugs made on both dedicated and non-dedicated equipment for the US market while it addresses the CGMP violations.

If a drug manufacturer intends to resume manufacturing activities, it must inform this agency beforehand, according to the USFDA.

According to a research, the country has over 600 USFDA-registered manufacturing facilities, accounting for almost 12.5% of all registered manufacturing sites operating outside the US.

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