FEI 2084177
Calatex, Inc.
1607 E McFadden Ave Ste H, Santa Ana, CA, US
MDR events0All time
Recalls0All time
Registered products1
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
1 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 2084177.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Aug 27, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Aug 27, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.50Aug 27, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.100(a)Aug 27, 2025
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.