FDA 483 - Alan Neuromedical Technologies - September 13, 2018

An FDA inspection of Alen Neuromedical Technologies in The Woodlands, TX, a medical device specification developer, revealed significant deficiencies in their quality system. Observations included a failure to evaluate and qualify contract manufacturers, inadequate maintenance of complaint files, and a lack of internal quality audits over several years. These issues indicate a need for improved adherence to quality system regulations for medical devices.