![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » FDA Flags Hand Biomechanics Over MDRs, CAPAs
FDA Flags Hand Biomechanics Over MDRs, CAPAs
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.
The facility also lacked complaint procedures to determine whether a complaint represents an event required to be reported to the FDA.
The FDA also found the company’s complaint-handling procedures included an evaluation for MDR reportability but did not treat death or serious injury as a reportable event.
Upcoming Events
-
21Oct