FDA 483 - Kenlor Industries, Inc. - May 03, 2019

Kenlor Industries, Inc. in Santa Ana, CA, a medical device manufacturer, was inspected by the FDA from April 29 to May 3, 2019. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate maintenance of device master records, lack of established procedures for design control, purchasing controls, process controls, equipment maintenance and calibration, complaint handling, and acceptance activities. These issues indicate a broad failure to adhere to quality system regulations for medical devices.