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Medical Devices / Inspections and Audits

FDA Flags Hand Biomechanics Over MDRs, CAPAs

Aug. 15, 2018
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Hand Biomechanics failed to complete package integrity validations and had incomplete medical device reporting procedures, the FDA said in a Form 483 issued after a March/April inspection of its Sacramento, California, facility.

Investigators found the company did not complete a package integrity validation for three products labeled as sterile.

The company also failed to initiate CAPA files for failures identified in a 2017 warning letter or to properly investigate the cause of loss in production control which led to non-conforming seal packaging.

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