Company
United StatesAmbulatory Monitoring Inc., Ardsley, NY – FDA Inspections
Inspection records and compliance data for Ambulatory Monitoring Inc. in Ardsley, New York. 5 FDA inspections on record, last inspected February 29, 2024.
Company Profile
This profile covers Ambulatory Monitoring Inc. based in Ardsley, New York, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 22, 2010. Last inspected February 29, 2024.
Most cited issue areas
- Acceptable supplier records, inadequate records1 inspection
- Design output - documentation1 inspection
- Documentation1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 29, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1231518 |
| July 5, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1062255 |
| August 25, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 945651 |
| April 5, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 826816 |
| June 22, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 671231 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Ambulatory Monitoring Inc.
FEI Number
2430863
Address
731 Saw Mill River Rd, Ardsley, New York 10502, United States
Country
United States
ID: be2fc372-539e-4f75-b5a2-268c6285fb97