FDA Cites Endoscopy Devicemaker for Design Reviews

The FDA hit a Canoga Park, California endoscopy device manufacturer with a Form 483 over a failure to document design reviews for multiple products.

An agency inspection found that National Advanced Endoscopy Devices did not document design review results in design history files in accordance with its design control procedure.

The design history files for the company’s laparoscope, arthroscope, cystoscope, bipolar forceps and resectoscope did not include the design, date and person conducting the review.