Tuxedo Imaging
159 S Main St Ste 414, Akron, OH, US
Registered product codes
2 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3021736604.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Sep 19, 2025
Compliance: Devices · Citations posted
Inspection citations
14 on file
Top cited requirements
Compare to industry ↗21 CFR 820.20(c)Management review - Lack of or inadequate procedures
121 CFR 820.22Quality audits - Lack of or inadequate procedures
121 CFR 820.25(b)Training - Lack of or inadequate procedures
121 CFR 820.30(e)Design review - Lack of or inadequate procedures
121 CFR 820.30(f)Design verification - Lack of or inadequate procedures
121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
1
- 21 CFR 820.20(c)Sep 19, 2025
Management review - Lack of or inadequate procedures
- 21 CFR 820.22Sep 19, 2025
Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Sep 19, 2025
Training - Lack of or inadequate procedures
- 21 CFR 820.30(e)Sep 19, 2025
Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Sep 19, 2025
Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(g)Sep 19, 2025
Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(h)Sep 19, 2025
Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(j)Sep 19, 2025
Design history file
- 21 CFR 820.40Sep 19, 2025
Procedures not adequately established or maintained
- 21 CFR 820.50Sep 19, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.100(a)Sep 19, 2025
Lack of or inadequate procedures
- 21 CFR 820.181Sep 19, 2025
DMR - not or inadequately maintained
- 21 CFR 820.184Sep 19, 2025
Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Sep 19, 2025
Lack of or inadequate complaint 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.