FDA Inspection
Integra LifeSciences CorporationIntegra LifeSciences Corporation – FDA Inspection, Jul 2, 2018
Record Details
This FDA Inspection record concerns Integra LifeSciences Corporation, with an inspection on July 2, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · def572e4-8bbb-4c35-83eb-3a5dc4b3f57d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1057633
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Integra LifeSciences Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2025 | Not classified | Cincinnati District Office | |
| May 2, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 16, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 22, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Integra LifeSciences Corporation
- FDA Inspection 1274595 - 2025-06-06
- FDA Inspection 973206 - 2016-05-02
- FDA Inspection 863101 - 2014-01-16
- FDA Inspection 715419 - 2011-03-22
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.