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Medical Devices / Inspections and Audits

DoubleDay Cited for Failure to Control Nonconforming Products

April 8, 2019
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DoubleDay Acquisitions failed to control products that didn’t meet specifications at its Moraine, Ohio manufacturing facility, the FDA discovered during a Dec. 10-14, 2018 inspection.

DoubleDay, which provides cold chain solutions, failed to document nonconformances for its AcuTemp AX56L blood storage refrigerator during in-process manufacturing, the agency said. According to the 483, the quality manager admitted to inspectors that in-process nonconformances aren’t documented for the AX56L.

The device history record showed the first test for the refrigerator failed, but this nonconformance wasn’t documented and the failed test was discarded instead of being kept with the device history record, the agency noted.

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