The FDA hit Greensboro, North Carolina devicemaker O.R. Surgical with a Form 483 for inadequate complaint handling and other deficiencies.
The agency’s Oct. 9-12, 2018 inspection of the plant revealed multiple repeat observations from a previous agency inspection. It found that the facility had not “established a procedure to ensure that all complaints are documented upon receipt, and complaints are reviewed and evaluated to determine if an investigation is necessary.”
The facility had no device history records and lacked any defined quality procedures, the investigator said.