FDA Inspection
ADDTO, INC.ADDTO, INC. – FDA Inspection, Jan 16, 2009
Record Details
This FDA Inspection record concerns ADDTO, INC., with an inspection on January 16, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ADDTO, INC.
- Inspection Date
- January 16, 2009
- Product Type
- Devices
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ID · ea1df837-dd0f-4cc1-9773-ca1a3e77e339
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 557503
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.184(d)Acceptance records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(a)Quality policy and objectives
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Other FDA inspections of ADDTO, INC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 29, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ADDTO, INC.
- FDA Inspection 907865 - 2014-12-29
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