Criticare Technologies, Inc.
333 Strawberry Field Rd, Warwick, RI, US
Registered product codes
6 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 3012238587.
FDA inspections
4 on file
- Official Action Indicated (OAI)Oct 28, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Oct 28, 2025
Postmarket Assurance: Devices · Citations posted
- Official Action Indicated (OAI)May 10, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)May 10, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
18 on file
Top cited requirements
Compare to industry ↗21 CFR 820.30(g)Design validation - Risk analysis
421 CFR 820.30(f)Design verification - output does not meet input requirement
221 CFR 820.50Purchasing controls, Lack of or inadequate procedures
221 CFR 820.100(a)Lack of or inadequate procedures
221 CFR 820.198(a)Lack of or inadequate complaint procedures
221 CFR 820.70(a)Production processes
1
- 21 CFR 820.30(f)Oct 28, 2025
Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Oct 28, 2025
Design validation - Risk analysis
- 21 CFR 820.30(g)Oct 28, 2025
Design validation- Lack of or inadequate procedures
- 21 CFR 820.50Oct 28, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Oct 28, 2025
Production processes
- 21 CFR 820.72(b)Oct 28, 2025
Remedial action
- 21 CFR 820.100(a)Oct 28, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(a)Oct 28, 2025
Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)May 10, 2024
Training records
- 21 CFR 820.30(f)May 10, 2024
Design verification - output does not meet input requirement
- 21 CFR 820.30(g)May 10, 2024
Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(g)May 10, 2024
Design validation- Lack of or inadequate procedures
- 21 CFR 820.50May 10, 2024
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.80(a)May 10, 2024
Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(a)May 10, 2024
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)May 10, 2024
Lack of or inadequate procedures
- 21 CFR 820.198(a)May 10, 2024
Lack of or inadequate complaint procedures
- 21 CFR 830.300(a)May 10, 2024
Devices subject to device identification GUDID data submission requirements.
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.