It has taken two years, but California-based contract manufacturer IriSys has moved out from under the shadow of an FDA warning letter.
The agency this week posted a closeout letter sent Sept. 24 to IriSys. The FDA said an evaluation showed that the company had resolved all of the violations at its San Diego plant that the agency had noted in an August 2010 warning letter.
The company had been cited for a number of problems, including not having adequate documentation for changes it had made for the manufacturer of Donnatal Elixir, an adjunctive therapy for treating irritable bowel syndrome. The letter said IriSys had made equipment and process changes, including the order in which it added raw ingredients, but had failed to confirm that the new process would meet specifications.
The letter also listed issues with equipment cleaning, saying that while it acknowledged the company's commitment to "reduce or eliminate microbiological growth conditions," the plan did not adequately explain how it would train employees to achieve that. Finally, the letter said IriSys was making and marketing the analgesic Treagan Otic, a drug for which it had not received FDA approval.
- here's the original warning letter
- here's the closeout letter