FDA Inspection
Neurodyne Medical CorporationNeurodyne Medical Corporation – FDA Inspection, Dec 2, 2011
Record Details
This FDA Inspection record concerns Neurodyne Medical Corporation, with an inspection on December 2, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 2, 2011
- Product Type
- Devices
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ID · 77212ab3-84dc-4f2b-8ff0-e4ffc0377bee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 754792
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.72(b)Remedial action - documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
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Other FDA inspections of Neurodyne Medical Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 13, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Neurodyne Medical Corporation
- FDA Inspection 554322 - 2008-11-13
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