FDA 483 - Diagnostica Stago, Inc. - September 04, 2024

Diagnostica Stago, Inc., a manufacturer and importer in Parsippany, NJ, was cited for significant deficiencies in its Medical Device Reporting (MDR) procedures and practices. The firm lacked specific internal guidance for MDR reporting, submitted reports containing multiple adverse events without proper exemptions, and failed to include required patient and importer information in its MDR submissions. These issues indicate a lack of adequate controls for post-market surveillance and regulatory compliance.