FDA Inspection
Integra LifeSciences CorporationIntegra LifeSciences Corporation – FDA Inspection, Nov 20, 2009
Record Details
This FDA Inspection record concerns Integra LifeSciences Corporation, with an inspection on November 20, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 20, 2009
- Product Type
- Devices
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ID · 3997764c-476d-4cdd-9606-35264f0f181c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 626583
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.198(d)Evaluation, timeliness, identification
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Other FDA inspections of Integra LifeSciences Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2024 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 15, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 17, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 14, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 30, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Integra LifeSciences Corporation
- FDA Inspection 1237437 - 2024-08-22
- FDA Inspection 1018575 - 2017-06-15
- FDA Inspection 949906 - 2015-12-17
- FDA Inspection 840748 - 2013-08-14
- FDA Inspection 786007 - 2012-07-30
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