OriGen Biomedical has been hit with a warning letter following the FDA’s inspection of its Austin, Texas facility, which revealed problems with the company’s controls for reworked products.
The agency, which inspected the site from June 11 to July 5, 2018, noted that the firm’s documentation of device reworking and reevaluation activities lacked an investigation into any adverse effects that resulted from the rework.
The FDA took issue with the firm’s rework of its VV14F dual lumen catheters, which were released and distributed despite failing endotoxin testing. The rework included a second ethylene oxide sterilization, but the facility failed to document that this had no adverse effect on the devices.
