FDA 483 - Kenlor Industries, Inc. - September 21, 2020

Kenlor Industries, Inc. in Santa Ana, CA, a medical device manufacturer, was cited with five observations during an FDA inspection. The inspection revealed significant deficiencies in quality system procedures, including inadequate finished device acceptance, equipment calibration, document control, management review documentation, and personnel training. These issues indicate a lack of robust controls over critical manufacturing and quality processes.