FDA Inspection
Axiom Worldwide,Inc.Axiom Worldwide,Inc. – FDA Inspection, Jul 10, 2009
Record Details
This FDA Inspection record concerns Axiom Worldwide,Inc., with an inspection on July 10, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Axiom Worldwide,Inc.
- Inspection Date
- July 10, 2009
- Product Type
- Devices
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ID · 9a6e8881-6daf-4fba-a11b-118639252cd1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 596268
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.100(a)(1)Analysis of data sources
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.70(a)Process control procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Axiom Worldwide,Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 27, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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