FDA Inspection
Holistic Technologies, LLCHolistic Technologies, LLC – FDA Inspection, Aug 23, 2019
Record Details
This FDA Inspection record concerns Holistic Technologies, LLC, with an inspection on August 23, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2a12891e-2bb5-48aa-8dbb-9acf865de87d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100308
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of Holistic Technologies, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 10, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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