FEI 3008720584
Ovesco Endoscopy Usa
15300 Weston Parkway, Cary, NC, US
MDR events5All time
Recalls0All time
Registered products16
Establishment typeComplaintComplaint File Establishment per 21 CFR 820.198
Registered product codes
16 product codes
Recent MDR events
5 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3008720584.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)May 22, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)May 22, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.20(c)May 22, 2025
Management review - Lack of or inadequate procedures
- 21 CFR 820.22May 22, 2025
Quality audits - Lack of or inadequate procedures
- 21 CFR 820.72(a)May 22, 2025
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.