FDA lambasts Kilitch for unsanitary manufacturing conditions and issues warning letter to Natco, too

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来源: FiercePharma

After inspections in recent months, the FDA has handed out a pair of warning letters to Indian drugmakers Kilitch Healthcare India and Natco Pharma.

It usually goes without saying that your pharmaceutical production workers need to be gowned and gloved while handling drug materials inside clean rooms. And, at the bare minimum, those workers ought to be wearing shoes.

Unfortunately for Kilitch Healthcare India, those simple standards weren’t upheld when inspectors from the U.S. FDA visited the company’s plant in Navi Mumbai, India, in October.

The FDA came out swinging against Kilitch in a four-observation warning letter this week, blasting the company for keeping its manufacturing facility “in a state of disrepair, poorly cleaned and maintained.”

FDA officials pointed to residue on HEPA filters, instances of operators using “visibly dirty” restricted access barrier systems to make adjustments on the filling line and—perhaps most egregiously—“multiple barefoot employees” who were handling materials being transferred to a production area.

The regulatory rebuke follows an inspection of Kilitch’s facility in Navi Mumbai from Oct. 12 to Oct. 20, 2023. Investigators issued the warning letter late last month after Kilitch failed to clean up its act following the receipt of a Form 483.

Breaking down the FDA’s specific observations, the agency chided Kilitch for “poor practices” tied to written procedures around microbial contamination, shoddy lab records, behaviors that could have caused contamination and quality control lapses.

In light of Kilitch’s manufacturing deviations, the FDA has recommended the company enlist a production consultant.

For its part, Kilitch has told the regulator it has suspended all production of drugs bound for the U.S. market. Now, the FDA wants to know whether Kilitch eventually plans to resume manufacturing for the U.S. from its Navi Mumbai factory.

Elsewhere, India's Natco Pharma received (PDF) its own FDA warning letter this week following an inspection of its Kothur plant in Telangana, India, according to a company filing on the Bombay Stock Exchange Tuesday.

Details on the FDA’s specific observations were sparse, with Natco stressing that it doesn’t believe the write-up will disrupt supply flow or existing sales from the facility. That said, the warning letter could delay or scupper pending product approvals from the site, Natco said.

Natco added that it will respond to the letter promptly and address the FDA’s concerns in a “holistic and timely manner.”

The FDA has distributed warning letters to a number of other companies this year, such as China’s Deebio Pharmaceuticals and Mexico’s Glicerinas Industriales.

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