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Medical Devices / Inspections and Audits

FDA Flags Hand Biomechanics Over MDRs, CAPAs

Aug. 15, 2018

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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