The Food and Drug Administration is warning Bloomington-based drug manufacturer Catalent Indiana LLC to address “significant violations” of good manufacturing practice.
That included cat hair around the stoppers of some vials filled at the Bloomington facility, in direct contact with drugs, the FDA reported.
Danish pharma company Novo Nordisk bought Bloomington’s Catalent plant last year, in part to produce the popular weight loss drug Wegovy.
The plant, Catalent Indiana LLC, is part of Novo Nordisk and no longer part of Catalent's network. A Catalent representative said the plant is in the process of being renamed.
“While we recognize that you worked with your suppliers to reduce the likelihood of mammalian hair contamination events, we are concerned that Novo Nordisk released batches in which your customers found mammalian hair contamination,” the FDA wrote in a letter last month.
Some batches were later recalled, but the FDA said the company continued to receive complaints from customers.
The agency said Catalent and Novo Nordisk didn’t start a timely investigation or take corrective actions.
Novo Nordisk did not respond to a request for comment, but told the FDA the cat hair likely came from its stopper suppliers.
The FDA is demanding an action plan and has threatened to withhold export certificates until the violations are fully addressed.
The FDA says the contamination dates to before the Novo Nordisk acquisition but that it continued “well after” the turnover.
Clarification: Following Novo Nordisk's acquisition of Catalent, the Bloomington facility is no longer part of Catalent's network.
