FDA Inspection
Advanced Back Technologies, Inc.Advanced Back Technologies, Inc. – FDA Inspection, Jan 26, 2011
Record Details
This FDA Inspection record concerns Advanced Back Technologies, Inc., with an inspection on January 26, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 26, 2011
- Product Type
- Devices
View Company Profile
ID · dad61ca5-21ff-45bc-af8a-8b2b05ad44e0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 707754
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(b)Documentation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Advanced Back Technologies, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2024 | NAI | New York District Office | Postmarket Assurance: Medical Devices |
| November 4, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 18, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 3, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 21, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Advanced Back Technologies, Inc.
- FDA Inspection 1254261 - 2024-10-31
- FDA Inspection 1158456 - 2021-11-04
- FDA Inspection 1097366 - 2019-07-18
- FDA Inspection 972354 - 2016-06-03
- FDA Inspection 923803 - 2015-04-21
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