FDA 483 - Elite-Medical, LLC - April 29, 2022

Elite-Medical, LLC in Florence, AL, a contract manufacturer, was inspected by the FDA and received a Form 483. The inspection revealed significant quality system deficiencies, including inadequate control of nonconforming products, failure to establish proper procedures for purchased products and services, and the use of obsolete documents for preventative maintenance. These observations indicate a need for improved adherence to quality system regulations.