DynaFlex failed to follow proper procedures for CAPA and design control, the FDA said in a Form 483.
The agency issued the form following an April inspection of the company’s St. Ann, Missouri facility. Investigators found the company’s CAPA procedures did not include an analysis of quality data to identify the causes of nonconformances and that the firm failed to validate corrective and preventive actions.
The facility also lacked design controls for its class 2 medical devices, including design history files, design inputs or outputs, verifications, transfers or design changes.
Investigators also found the validation of machines used for manufacturing did not include documentation of the approval of process changes or the acceptance criteria for review and approval of the validation.
The FDA also found the device master record for the company’s sleep apnea device did not include components such as production methods or procedures, packaging and labeling specifications, quality assurance and acceptance procedures, or drawings, compositions and specifications of the appliance.
Lastly, the agency found the company did not include rework activities and evaluations in its device history records, and the records did not include the primary identification label and labeling used for each production unit.