The FDA cited Columbus, Ohio device manufacturer GFS Chemicals over multiple issues at its facility, including complaint and supplier handling, hitting the company with a Form 483.

During its April 15-24 inspection of the site, the agency noted that the firm did not adequately handle complaints, as it was not recording the dates it received them.

The devicemaker also received manufacturing materials from a supplier that was not found on its approved supplier list, an issue the agency said was a recurring observation.