Clearlake-tech Inc
205 Hwy 22 E, Clear Lake, SD, US
Registered product codes
13 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 1721293.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Sep 30, 2024
Project Evaluation: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.72(b)Calibration procedures - content
121 CFR 820.75(a)Lack of or inadequate process validation
121 CFR 820.80(d)Lack of or inadequate final acceptance procedures
121 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
1
- 21 CFR 820.50Sep 30, 2024
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.72(b)Sep 30, 2024
Calibration procedures - content
- 21 CFR 820.75(a)Sep 30, 2024
Lack of or inadequate process validation
- 21 CFR 820.80(d)Sep 30, 2024
Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Sep 30, 2024
Nonconforming product, 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.