Plaxtron Industrial (m) Sdn. Bhd.
PLOT 28, KAWASAN PERUSAHAAN, IPOH Perak, MY
Registered product codes
23 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 1000283452.
FDA inspections
2 on file
- Official Action Indicated (OAI)Aug 15, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Aug 15, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
121 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
121 CFR 820.75(a)Lack of or inadequate process validation
121 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
121 CFR 820.100(a)Lack of or inadequate procedures
121 CFR 820.184DHR content
1
- 21 CFR 820.70(c)Aug 15, 2024
Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Aug 15, 2024
Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.75(a)Aug 15, 2024
Lack of or inadequate process validation
- 21 CFR 820.75(b)Aug 15, 2024
Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.100(a)Aug 15, 2024
Lack of or inadequate procedures
- 21 CFR 820.184Aug 15, 2024
DHR content
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.