FDA Inspection
DavisMade, Inc.DavisMade, Inc. – FDA Inspection, Sep 17, 2009
Record Details
This FDA Inspection record concerns DavisMade, Inc., with an inspection on September 17, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DavisMade, Inc.
- Inspection Date
- September 17, 2009
- Product Type
- Devices
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ID · 0a76c07e-8bc4-4c65-b1dc-9b5f71e02f59
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 614230
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(a)General
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.181(d)DMR packaging and labeling specifications
- 21 CFR 820.100(b)Procedures
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Other FDA inspections of DavisMade, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 21, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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