FDA slams Natco Pharma with Form 483 over sanitary, quality control problems

India’s Natco Pharma was hit with a Form 483 by the FDA following an inspection that resulted in eight observations. The citation centered on a lack of cleanliness and sterility of equipment plus problems with record-keeping and the site’s quality control systems.

The inspection, which was conducted at the company’s Kothur facility in India, took place between Oct. 9 and Oct. 18, the agency said in a heavily redacted, 27-page letter posted on its website.

Inspectors found that the company did not clean and properly maintain equipment and utensils to prevent contamination. This could alter the safety, strength and quality of the drug being produced, according to the FDA.

“Test data revealed the presence of different (redacted) drug substances present as high as up to about 800 times the acceptance limit,” the agency said.

Swab samples taken by inspectors showed the potential for cross-contamination, the FDA further stated.

Additionally, the company was cited for not having written responsibilities and procedures for the quality control unit, lacking procedures to prevent microbiological contamination, failing to review unexplained discrepancies of batch failures and other record-keeping problems.

This isn't Natco's first run-in with the FDA's manufacturing compliance group. Back in 2019, the company’s Mekaguda plant received a Form 483 that cited six observations.

At the time, the company said it was investing in its Kothur facility in anticipation of approval of its generic version of big-selling cancer drug Revlimid.