FDA 483 - Geneoscopy, Inc. - May 17, 2023

An FDA inspection of Geneoscopy, Inc., a medical device manufacturer in Saint Louis, MO, identified two significant observations related to quality system procedures. The firm failed to establish procedures for finished device acceptance and adequately establish procedures for device history records, specifically concerning their Stool Sample Collection kits. These issues indicate deficiencies in ensuring proper control and documentation of medical device manufacturing and release.