FEI 3003282181
Kawasumi Laboratories (thailand) Co., Ltd.
48 MU 8, RATCHASIMA-CHOK CHAI RD,, CHOK CHAI Nakhon Ratchasima, TH
MDR events0All time
Recalls0All time
Registered products10
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
10 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 3003282181.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Jul 25, 2024
Compliance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.20(a)Jul 25, 2024
Management ensuring quality policy is understood
- 21 CFR 820.22Jul 25, 2024
Quality audits - Lack of or inadequate procedures
- 21 CFR 820.70(g)(2)Jul 25, 2024
Periodic equipment inspection lack of or inadequate procedu
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.