FDA Issues Warning Letter to I-Flow for Nonconformance

The U.S. Food and Drug Administration (FDA) has issued a 19-page warning letter to I-Flow Corp. for releasing devices that do not meet output validation criteria and for downplaying nonconformances in its corrective action procedures.
 
The Lake Forest, Calif.-based company, which makes elastomeric infusion pumps, did not test the devices during or after design output procedures to ensure they met design specifications for correct flow rates, which is “essential to verifying that the device is functioning,” according to the December letter.

The FDA cited I-Flow for not implementing procedures to verify the device design and failing to address unresolved discrepancies after testing.
 
FDA inspectors investigated the company’s plant in March and May of last year. I-Flow responded to the FDA inspections in three separate letters, but the agency said many of the company’s responses were inadequate.

“I-Flow has responded to the letter, is working with the FDA and has implemented a comprehensive plan to address the FDA’s observations,” said I-Flow spokesman Neil Berkman.

The company may face civil penalties and product seizure if it doesn’t promptly correct the actions, according to the FDA letter.