Kenlor Informed of Device Acceptance Procedure Findings

Failure to establish and document finished-device acceptance procedures and to sufficiently calibrate equipment were among the quality deviations that the FDA observed during a Sept. 15-21 inspection of Kenlor Industries’ Santa Ana, Calif., facility.

The company develops stabilized urinalysis liquid-control products for clinical testing, but it lacked finished-device acceptance procedures to ensure that the finished devices were quarantined and not released until acceptance activities were completed, according to the Form 483 inspection report.

The FDA investigator noted that the device history record showed several instances in which a urine-dipstick control failed quality testing and acceptance testing was not documented but the product was packaged and released.