FDA 483 - Slater Endoscopy, LLC - February 02, 2023

Slater Endoscopy, LLC, a medical device manufacturer in Miramar, FL, was inspected by the FDA from January 31 to February 2, 2023. The inspection revealed a deficiency in document control procedures, specifically regarding the updating of Design History Files and Device Master Records after material and process changes. This indicates a moderate compliance issue related to quality system documentation.