FDA Inspection
Ambulatory Monitoring Inc.Ambulatory Monitoring Inc. – FDA Inspection, Apr 5, 2013
Record Details
This FDA Inspection record concerns Ambulatory Monitoring Inc., with an inspection on April 5, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ambulatory Monitoring Inc.
- Inspection Date
- April 5, 2013
- Product Type
- Devices
View Company Profile
ID · 64f76e97-ab1e-4db2-ae86-8aa2cd867241
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 826816
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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 |
| June 22, 2010 | VAI | Center for Devices and Radiological Health | Compliance: 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 671231 - 2010-06-22
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