FDA Inspection
Integra LifeSciences Corp.Integra LifeSciences Corp. – FDA Inspection, Jan 20, 2010
Record Details
This FDA Inspection record concerns Integra LifeSciences Corp., with an inspection on January 20, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Integra LifeSciences Corp.
- Inspection Date
- January 20, 2010
- Product Type
- Devices
View Company Profile
ID · d16b66cf-4ac1-40b0-965b-39b5770b98ea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 646649
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.80(d)(2)Review of data and documentation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.22Quality Audit/Reaudit - conducted
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Integra LifeSciences Corp.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 9, 2019 | Not classified | Denver District Office | |
| October 21, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 1, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Integra LifeSciences Corp.
- FDA Inspection 1285052 - 2025-09-17
- FDA Inspection 1132558 - 2019-08-09
- FDA Inspection 993197 - 2016-10-21
- FDA Inspection 831146 - 2013-05-01
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.