FDA Inspection
Neuro-Fitness LLCNeuro-Fitness LLC – FDA Inspection, Jul 7, 2017
Record Details
This FDA Inspection record concerns Neuro-Fitness LLC, with an inspection on July 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c92dcd96-e64b-46f0-b7c2-b8f98fa3156f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017141
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Neuro-Fitness LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 21, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 22, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 30, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Neuro-Fitness LLC
- FDA Inspection 1181655 - 2022-10-18
- FDA Inspection 1111026 - 2019-11-21
- FDA Inspection 769059 - 2012-02-22
- FDA Inspection 683443 - 2010-09-30
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