FEI 3010166880
Leesar, Inc.
2727 Winkler Ave, Fort Myers, FL, US
MDR events8All time
Recalls0All time
Registered products4
Establishment typeRepackRepack or Relabel Medical Device
Registered product codes
4 product codes
Recent MDR events
8 on file
- LSRHKGYNSep 18, 2018Malfunction7884758
- LAPAROSCOPIC CHOLECYSTECTOMY KITDec 7, 2015Malfunction5270146
- KIMBERLY CLARKSep 25, 2015Malfunction5103780
- SPONGESSep 25, 2015Malfunction5103781
- LAP CHOLE SPONGE PACKSep 25, 2015Malfunction5103785
- SPONGESSep 24, 2015Malfunction5100446
- SPONGESSep 24, 2015Malfunction5100447
- SPONGESep 24, 2015Malfunction5100470
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3010166880.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jul 18, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Jul 18, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.20(c)Jul 18, 2025
Management review - Lack of or inadequate procedures
- 21 CFR 820.22Jul 18, 2025
Quality audits - Lack of or inadequate procedures
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.