FDA Inspection
Depuy International Ltd.Depuy International Ltd. – FDA Inspection, Jun 25, 2015
Record Details
This FDA Inspection record concerns Depuy International Ltd., with an inspection on June 25, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Depuy International Ltd.
- Inspection Date
- June 25, 2015
- Product Type
- Devices
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ID · 3e7e3c85-56b5-4f7e-84e3-ea172a0d162c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 935017
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Depuy International Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 26, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 16, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Depuy International Ltd.
- FDA Inspection 1019226 - 2017-05-26
- FDA Inspection 772653 - 2012-02-16
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