Exactech Sarasota
7455 16th Street East, Sarasota, FL, US
Registered product codes
12 product codes
Recent MDR events
1 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3008658204.
FDA inspections
1 on file
- Official Action Indicated (OAI)Jul 25, 2025
Compliance: Devices · Citations posted
Inspection citations
7 on file
Top cited requirements
Compare to industry ↗21 CFR 820.25(b)Training - Lack of or inadequate procedures
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
121 CFR 820.70(c)Environmental control Lack of or inadequate procedures
121 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
121 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
1
- 21 CFR 820.25(b)Jul 25, 2025
Training - Lack of or inadequate procedures
- 21 CFR 820.50Jul 25, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Jul 25, 2025
Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(c)Jul 25, 2025
Environmental control Lack of or inadequate procedures
- 21 CFR 820.80(a)Jul 25, 2025
Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(a)Jul 25, 2025
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Jul 25, 2025
Lack of or inadequate procedures
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.