FDA Inspection
Integra LifeSciences CorporationIntegra LifeSciences Corporation – FDA Inspection, Aug 25, 2011
Record Details
This FDA Inspection record concerns Integra LifeSciences Corporation, with an inspection on August 25, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 25, 2011
- Product Type
- Devices
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ID · d9276d8f-0cfd-4714-8cd1-6c01ca93e5d3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 735982
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(f)Buildings
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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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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