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Medical Devices / Inspections and Audits

FDA Flags Cadwell Industries for CAPAs, Complaints, Design Validation

Dec. 6, 2017

The FDA observed nonconformities related to CAPAs, complaint handling and design validation at Cadwell Industries’ manufacturing facility in Kennewick, Washington.

The facility had no documented plan for verifying the effectiveness, as required by the firm’s CAPA procedure, of at least two CAPAs that had already been marked as effective, according to the Form 483 issued after an August inspection.

The agency’s investigator also found three complaints regarding devices that were returned to Cadwell more than a year ago that had not been evaluated.

In addition, the firm had failed to follow its validation procedure for the IOMAX device as production equivalent devices were not used for testing.

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