FDA Inspection
Integra Lifesciences (Ireland) LimitedIntegra Lifesciences (Ireland) Limited – FDA Inspection, Sep 30, 2010
Record Details
This FDA Inspection record concerns Integra Lifesciences (Ireland) Limited, with an inspection on September 30, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 30, 2010
- Product Type
- Devices
View Company Profile
ID · 919d415b-f6b1-40bb-8c6e-bbcd3398f276
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 694696
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
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Other FDA inspections of Integra Lifesciences (Ireland) Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2018 | Not classified | Office of Inspections and Investigations | |
| April 26, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 5, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 23, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Integra Lifesciences (Ireland) Limited
- FDA Inspection 1094949 - 2018-12-14
- FDA Inspection 1072147 - 2018-04-26
- FDA Inspection 919158 - 2015-03-05
- FDA Inspection 799848 - 2012-08-23
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