FDA Inspection
Holistic Technologies, LLCHolistic Technologies, LLC – FDA Inspection, Jul 10, 2012
Record Details
This FDA Inspection record concerns Holistic Technologies, LLC, with an inspection on July 10, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Holistic Technologies, LLC
- Inspection Date
- July 10, 2012
- Product Type
- Devices
View Company Profile
ID · 67c53448-440d-4727-8662-d227bc97cb8a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 789947
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Holistic Technologies, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 23, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 23, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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