Boulder Biomed Llc
5421 Western Avenue, Boulder, CO, US
Registered product codes
30 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 3015151147.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Oct 30, 2023
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Oct 30, 2023
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
121 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
121 CFR 820.75(a)Lack of or inadequate process validation
121 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
121 CFR 820.100(a)Lack of or inadequate procedures
1
- 21 CFR 820.50(a)(3)Oct 30, 2023
Acceptable supplier records, inadequate records
- 21 CFR 820.70(a)Oct 30, 2023
Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Oct 30, 2023
Lack of or inadequate process validation
- 21 CFR 820.90(a)Oct 30, 2023
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Oct 30, 2023
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.