FDA Inspection
NEBA Health LLCNEBA Health LLC – FDA Inspection, Nov 3, 2016
Record Details
This FDA Inspection record concerns NEBA Health LLC, with an inspection on November 3, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 42c045f1-8717-448e-8e7c-fb8634471af8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 991769
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of NEBA Health LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 10, 2008 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for NEBA Health LLC
- FDA Inspection 541565 - 2008-10-10
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