Dental X-Ray Manufacturer Warned for Design Control Shortcomings

October 16, 2019

The FDA hit dental x-ray devicemaker Denterprise International with a warning letter for design control violations at its Ormond Beach, Florida facility.

The agency’s inspection revealed numerous failures to establish design control procedures, including procedures for design inputs, outputs, review and verification.

The firm also lacked design control procedures for validations, transfers and changes, and didn’t have design history files for each type of device, the agency said.

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