The QMN Weekly Bulletin
Medical Devices / Inspections and Audits

Danmar Flagged for CAPA Records, Equipment Calibration

April 20, 2018

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, Mich., 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 as required by company’s standard operating procedures.

The company also did not adequately document its CAPA enforcement. Investigators found a CAPA the company opened on July 29, 2015 was closed in May 2016 without documenting the effectiveness of the actions taken.

The company also did not adequately document acceptance activities. Of 17 device history records and nine receiving reports the FDA reviewed, none identified the equipment used in acceptance activities. Lastly, the firm maintained no records of a correction or removal that justified not reporting it to the FDA.

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