Anesthesia Associates, Inc.
460 Enterprise Street, SAN MARCOS, CA, US
Registered product codes
31 product codes
Recent MDR events
3 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 2022648.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Dec 18, 2023
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Dec 18, 2023
Postmarket Assurance: Devices · Citations posted
Inspection citations
7 on file
Top cited requirements
Compare to industry ↗21 CFR 820.30(j)Design history file
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
121 CFR 820.100(a)Lack of or inadequate procedures
121 CFR 820.181DMR - not or inadequately maintained
121 CFR 820.184Lack of or inadequate DHR procedures
1
- 21 CFR 820.30(j)Dec 18, 2023
Design history file
- 21 CFR 820.50Dec 18, 2023
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.80(a)Dec 18, 2023
Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Dec 18, 2023
Lack of or inadequate procedures
- 21 CFR 820.181Dec 18, 2023
DMR - not or inadequately maintained
- 21 CFR 820.184Dec 18, 2023
Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Dec 18, 2023
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.