Integra Lifesciences Production Corporation
11 Cabot Blvd., Mansfield, MA, US
Registered product codes
277 product codes
Recent MDR events
81 on file
- HUNTER BOWEL GRASPER 18 R.L SLIDE LK INS 5MMJul 21, 2026MalfunctionMW5190937
- INTEGRA JARITJul 9, 2026Malfunction25762383
- INTEGRA®Jun 29, 2026Malfunction25651161
- CODMAN (BIPOLAR CORD UNITIZED PLUG, DISPOSABLEJun 22, 2026MalfunctionMW5189760
- LEWIN CLAMPJun 9, 2026InjuryMW5189083
- INTEGRA® MILTEX®May 15, 2026Malfunction25183753
- INTEGRA® MILTEX®May 14, 2026Malfunction25170522
- INTEGRA® MILTEX®Apr 20, 2026Malfunction24924813
- INTEGRA® JARIT®Apr 7, 2026Malfunction24799480
- INTEGRA® JARIT®Dec 8, 2025Malfunction23735743
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3014334038.
FDA inspections
1 on file
- Official Action Indicated (OAI)Jun 5, 2024
Compliance: Devices · Citations posted
Inspection citations
7 on file
Top cited requirements
Compare to industry ↗21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
121 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
121 CFR 820.75(a)Lack of or inadequate process validation
121 CFR 820.80(d)Lack of or inadequate final acceptance procedures
121 CFR 820.90(a)Nonconforming product control
121 CFR 820.100(b)Documentation
1
- 21 CFR 820.70(c)Jun 5, 2024
Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(e)Jun 5, 2024
Contamination control, Lack of or inadequate procedures
- 21 CFR 820.75(a)Jun 5, 2024
Lack of or inadequate process validation
- 21 CFR 820.80(d)Jun 5, 2024
Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Jun 5, 2024
Nonconforming product control
- 21 CFR 820.100(b)Jun 5, 2024
Documentation
- 21 CFR 820.150Jun 5, 2024
Lack of or inadequate procedures for storage.
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.