FDA 483 - Exact Medical Manufacturing, Inc. - November 21, 2017

An FDA inspection of Exact Medical Manufacturing, Inc. in Lancaster, NY, a medical device specification developer, identified three significant issues related to their quality system. The firm was cited for inadequate procedures for training, deficiencies in their corrective and preventive action (CAPA) system, and a lack of approval signatures on critical documents. These observations indicate a need for improved adherence to quality system regulations.