Access Point Technologies EP, Inc. – FDA 483, Dec 20, 2022

An FDA inspection of Access Point Technologies in Rogers, MN, a medical device manufacturer, identified significant deficiencies in their quality system. The firm failed to adequately establish and implement procedures for monitoring validated process parameters, resulting in non-conforming product without appropriate corrective action. Additionally, procedures for in-process product acceptance were not properly implemented, leading to concerns about data integrity and a lack of rejection for out-of-specification materials.