483
Ambulatory Monitoring Inc.Ambulatory Monitoring Inc. – FDA 483, Feb 29, 2024
Record Details
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.
View Company Profile
ID · 9c9e0734-0acf-4ea8-acbc-018577104e7a
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.