USFDA fines Natco Pharma for inadequate manufacturing at its Telangana facility

USFDA fines Natco Pharma for inadequate manufacturing at its Telangana facility

The US Food and Drug Administration warned the corporation in a warning letter that its inspectors found many infractions at the completed pharmaceuticals factory in Kothur Village, Telangana.

The US health agency claims Natco Pharma neglected to keep its Telangana factory clean and to sanitize its tools and equipment on schedule.

The US Food and Drug Administration warned the corporation in a warning letter that its inspectors found many infractions at the completed pharmaceuticals factory in Kothur Village, Telangana.

From October 9 to October 18, 2023, the USFDA examined the plant.

"Your firm failed to clean, maintain, and, as appropriate for the environment of the drug, sanitize and/or sterilise the machinery and instruments at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the medicinal substance beyond the official or other established requirements," the US Food and Drug Administration stated.

It went on to say: "Your cleaning procedure for your non-dedicated equipment is inadequate." According to the USFDA, cross-contamination is not consistent and testing of placebo batches and control samples was unable to demonstrate to scientists that goods are free of contaminants from obviously unclean equipment.

You fail to recognize that other sites and sampling may show significant levels of contamination, and you do not adequately manage contamination retrieved from product contact surfaces," it said.

The US health authorities went on to say that the business neglected to fully look into any inconsistency or batch or component failure that did not match criteria, regardless of batch distribution history.

The USFDA requested a thorough, unbiased evaluation of your whole system for looking into complaints, deviations, inconsistencies, failures, and outcomes that are not in line with specifications.

It said to provide a report assessing staff members' investigative skills, their ability to carry out root cause analyses, and their ability to ensure the efficacy of corrective and preventative actions (CAPAs).

"We acknowledge your commitment to temporarily suspend creating all drugs manufactured on all dedicated as well as non-dedicated equipment to feed the US market while you remediate the CGMP violations," it said.

According to USFDA, if the pharmaceutical company intends to restart manufacture, it must first inform this agency before starting up again.

When a US health agency determines that a manufacturer has seriously broken its rules, it issues a warning letter.

Outside of the US, India is the country with the most USFDA-compliant pharmaceutical factories.

Over 600 USFDA-registered manufacturing facilities, or over 12.5% of all registered manufacturing sites operating outside the US, are located in the nation, according to a research.