FDA Inspection
Ansen CorpAnsen Corp – FDA Inspection, Mar 7, 2012
Record Details
This FDA Inspection record concerns Ansen Corp, with an inspection on March 7, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ansen Corp
- Inspection Date
- March 7, 2012
- Product Type
- Devices
View Company Profile
ID · e1848860-5a0b-45d4-ba36-4345f8a615d7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 771812
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ansen Corp
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 9, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 24, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ansen Corp
- FDA Inspection 673556 - 2010-07-09
- FDA Inspection 600039 - 2009-07-24
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