FEI 3007516837
Pt. Team Metal Indonesia
JLN. BRIGJEN KATAMSO NO. 6 - 8, BATAM Riau, ID
MDR events0All time
Recalls0All time
Registered products4
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
4 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 3007516837.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Dec 4, 2024
Compliance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.70(b)Dec 4, 2024
Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.75(a)Dec 4, 2024
Lack of or inadequate process validation
- 21 CFR 820.100(b)Dec 4, 2024
Documentation
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.