FDA Issues CrystalBraces Warning Letter for Procedural, Validation Failures

CrystalBraces has received an FDA warning letter for failing to adhere to several procedural and validation requirements for a dental aligner.

In an Oct. 30, 2015, warning letter that resulted from a Sept. 16 to 23, 2015 inspection at the company’s two facilities in Dallas, Texas, the FDA cites CrystalBraces with failing to maintain device master records and device history records and failing to establish design control procedures.

The warning letter also says the company failed to conduct inspections or tests for incoming components, ensure that received products conform to specified requirements or establish procedures to control manufacturing.

In addition, CrystalBraces failed to validate computer software as part of production activities and validate the manufacturing process, the FDA says.

CrystalBraces could not be reached for comment by press time.

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