FDA Inspection
Advanced Monitored Caregiving, Inc.Advanced Monitored Caregiving, Inc. – FDA Inspection, Dec 11, 2009
Record Details
This FDA Inspection record concerns Advanced Monitored Caregiving, Inc., with an inspection on December 11, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 11, 2009
- Product Type
- Devices
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ID · ef1bc785-36eb-4bc4-88f6-5ccf0f59dec5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 633823
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
17- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.198(a)General
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
Showing 10 of 17 citations.
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Other FDA inspections of Advanced Monitored Caregiving, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2025 | VAI | New York District Office | Compliance: Medical Devices |
| November 12, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 29, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 28, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 22, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Advanced Monitored Caregiving, Inc.
- FDA Inspection 1261620 - 2025-01-31
- FDA Inspection 1132941 - 2020-11-12
- FDA Inspection 1048073 - 2018-03-29
- FDA Inspection 912222 - 2015-01-28
- FDA Inspection 819732 - 2013-02-22
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