FDA 483 - Ambulatory Monitoring Inc. - February 29, 2024

Ambulatory Monitoring Inc., a medical device manufacturer in Ardsley, NY, was cited for two observations during an FDA inspection. The firm failed to maintain proper records for complaint investigations and lacked developed written Medical Device Reporting (MDR) procedures, including eMDR procedures and an ESG account setup. These issues indicate deficiencies in quality system controls related to complaint handling and adverse event reporting.