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Medical Devices / Inspections and Audits

California Devicemaker Hit With 483 Over CAPAs, Complaint Handling

Aug. 10, 2018

The FDA issued a Form 483 to Sacramento, California-based devicemaker Hand Biomechanics Lab, citing the company for failing to establish CAPA procedures and inadequate complaint handling.

Specifically, the firm was scolded for failing to provide justification for not opening CAPA files for various issues, including when it failed to investigate the cause of a loss in production control that resulted in the production of inadequate seal packaging.

Additionally, the firm’s complaint procedure for negative customer feedback did not consider death or serious injury as a reportable event.

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