FDA Warns Company for Releasing Nonconforming Devices

The FDA cited I-Flow Corp. for releasing devices that did not meet its output validation criteria and for downplaying the nonconformances in its corrective action procedures, according to a warning letter.

The California company, which manufactures 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,” the FDA says in the letter.

The FDA cited I-Flow for not implementing procedures to verify the device design and failing to address unresolved discrepancies after testing. I-Flow’s pre-sterilization and post-sterilization flow rate specifications were not consistent, the letter says.
The GMP Letter