FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

GEM City Engineering Lacking in Controls, Device Acceptance Procedures

Aug. 21, 2018
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A litany of major GMP deficiencies — ranging from inadequate document control procedures, CAPA, device acceptance procedures and procedures to control product — plagued GEM City Engineering and Manufacturing during a Feb. 21 to March 1 FDA inspection of its Dayton, Ohio facility.

The eight-item 483 cited numerous examples of the contract manufacturer’s faulty document control procedures. For example, document changes didn’t include a valid signature of the person approving the change, and procedures referenced documents that were not approved. The CMO’s supplier survey for its medical device metal supplier included a checklist that was not defined in the procedures, the 483 said.

Corrective and preventive action procedures were found lacking because none of the corrective action reports reviewed included a verification or validation prior to closing the corrective action reports.

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