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.