Surgical Direct, Inc. of Orange City was cited five times by the Food and Drug Administration (FDA) during an inspection conducted March 24, based on information from the FDA’s website.
The inspection included placement checks for:
- Device compliance
- Device postmarket assurance
The FDA noted the following findings for the company:
- ‘Records of quality management system software validation activities were not maintained.’
- ‘Procedures for management review have not been adequately documented.’
- ‘One or more processes for risk management in product realization have not been documented.’
- ‘Records of servicing activities carried out by your firm were not maintained.’
- ‘Complaint handling records were not adequately maintained.’
The FDA regularly examines sites nationwide to check if workplaces and their products meet FDA regulations aimed at improving public health, and makes those outcomes available to the public.
The agency’s website states the FDA oversees the safety and quality of human and animal drugs, biological products, medical devices and tobacco products.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.