FDA 483 - Alpha ProTech Inc. - May 11, 2023

Alpha ProTech Inc. in Salt Lake City, UT, a medical device manufacturer, received a Form FDA-483 with five observations. The inspection revealed significant issues with process validation, equipment qualification, CAPA documentation, complaint handling, and the maintenance of device history and master records, particularly concerning their N95 respirators. Several observations were repeats from a previous inspection, indicating persistent quality system deficiencies.