FDA 483 - ADMI - June 03, 2022

An FDA inspection of ADMI, a manufacturer in East Syracuse, NY, from May 26 to June 3, 2022, identified significant deficiencies in the firm's quality system. Observations included a failure to maintain and provide accessible records, a lack of established procedures for device history records, and an absence of equipment maintenance schedules. These issues indicate a concerning lack of control over critical manufacturing processes and documentation.