FDA 483 - Allen Milling Technologies - November 17, 2020

An FDA inspection of Allen Milling Technologies, a medical device manufacturer in Glendora, CA, revealed significant deficiencies in their quality system. Observations included a lack of documented personnel training, failure to conduct internal quality audits, and inadequate documentation of acceptance activities for both incoming and finished products. These issues indicate a fundamental breakdown in adherence to established procedures and quality control.