FDA Inspection
Ambulatory Monitoring Inc.Ambulatory Monitoring Inc. – FDA Inspection, Jun 22, 2010
Record Details
This FDA Inspection record concerns Ambulatory Monitoring Inc., with an inspection on June 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ambulatory Monitoring Inc.
- Inspection Date
- June 22, 2010
- Product Type
- Devices
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ID · 60c9a250-1145-4663-b6d4-a5e74d435ccf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 671231
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.80(e)Documentation
- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.22Quality Audit/Reaudit - conducted
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ambulatory Monitoring Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 29, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 |
Other documents for Ambulatory Monitoring Inc.
- FDA Inspection 1231518 - 2024-02-29
- FDA Inspection 1062255 - 2018-07-05
- FDA Inspection 945651 - 2015-08-25
- FDA Inspection 826816 - 2013-04-05
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