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Medical Devices / Inspections and Audits

Siemens Healthcare Diagnostics Flagged for Equipment Maintenance, CAPA Issues

Aug. 10, 2018

Siemens Healthcare Diagnostics fell short on CAPA procedures, acceptance activities and equipment maintenance, the FDA said in a Form 483 issued the form after a February/March inspection of the devicemaker’s East Walpole, Massachusetts, facility.

FDA officials found the company failed to verify the effectiveness of three CAPAs and its investigations of deviations or out-of-specification results observed during quality control acceptance activities were not properly documented, the agency said.

The FDA also faulted the Siemens facility for not properly verifying the accuracy of the reagent expiration dates its software calculated and generated.

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