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Medical Devices / Inspections and Audits

Danmar Flagged for CAPA Records, Equipment Calibration

April 19, 2018
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The FDA cited Danmar Products over inadequate calibration of equipment and procedures for accepting incoming products.

The agency issued a Form 483 after a November 2017 inspection of the company’s Ann Arbor, Michigan facility. Investigators found during a walkthrough that several products were past their calibration due dates. Moreover, the firm did not follow its procedures for evaluating and approving suppliers and monitoring their performance.

Danmar did not sample enough products per lot to fulfill the requirements of its sampling plan for two of nine receiving reports the agency reviewed.

The agency also faulted the company on its CAPA handling, writing that in at least six nonconformance investigation reports it did not justify its lack of corrective action.

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