FDA Inspection
Datcard Systems IncDatcard Systems Inc – FDA Inspection, Jul 17, 2009
Record Details
This FDA Inspection record concerns Datcard Systems Inc, with an inspection on July 17, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Datcard Systems Inc
- Inspection Date
- July 17, 2009
- Product Type
- Devices
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ID · a64b9c51-1715-42a2-b5b4-2997083e6234
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 601872
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.198(a)General
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(a)Specific non-conforming product procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Datcard Systems Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 25, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Datcard Systems Inc
- FDA Inspection 871406 - 2014-03-25
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