FDA Inspection
Ambulatory Monitoring Inc.Ambulatory Monitoring Inc. – FDA Inspection, Feb 29, 2024
Record Details
This FDA Inspection record concerns Ambulatory Monitoring Inc., with an inspection on February 29, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2604efbf-bc1b-400f-b56a-80678d247b07
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1231518
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(e)Maintained
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ambulatory Monitoring Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 5, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 25, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 5, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 22, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ambulatory Monitoring Inc.
- FDA Inspection 1062255 - 2018-07-05
- FDA Inspection 945651 - 2015-08-25
- FDA Inspection 826816 - 2013-04-05
- FDA Inspection 671231 - 2010-06-22
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