FDA Inspection
Innovative Health Technologies, LLCInnovative Health Technologies, LLC – FDA Inspection, Nov 22, 2011
Record Details
This FDA Inspection record concerns Innovative Health Technologies, LLC, with an inspection on November 22, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 22, 2011
- Product Type
- Devices
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ID · 29f786c0-9a42-4fbf-b85e-dca7e0d14326
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 754176
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
16- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
Showing 10 of 16 citations.
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Other FDA inspections of Innovative Health Technologies, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 20, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Innovative Health Technologies, LLC
- FDA Inspection 1042529 - 2018-02-28
- FDA Inspection 884777 - 2014-06-20
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