FDA Inspection
Nelson-MillerNelson-Miller – FDA Inspection, Nov 18, 2011
Record Details
This FDA Inspection record concerns Nelson-Miller, with an inspection on November 18, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Nelson-Miller
- Inspection Date
- November 18, 2011
- Product Type
- Devices
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ID · c9e9ebbd-5763-4c80-8c5d-430e15f75bac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 753952
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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Other FDA inspections of Nelson-Miller
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 18, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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