Aju Medical Co., Ltd.
Room 201, Room 207, BL A, 697, Pangyo-ro, Bundang-gu, Seongnam-si Gyeonggi, KR
Registered product codes
5 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 3014232239.
FDA inspections
2 on file
- Official Action Indicated (OAI)Jan 23, 2025
Compliance: Devices · Citations posted
- Official Action Indicated (OAI)Jan 23, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
8 on file
Top cited requirements
Compare to industry ↗21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
221 CFR 803.17Lack of Written MDR Procedures
121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.100(a)Lack of or inadequate procedures
121 CFR 820.198(a)Lack of or inadequate complaint procedures
1
- 21 CFR 803.17Jan 23, 2025
Lack of Written MDR Procedures
- 21 CFR 820.30(g)Jan 23, 2025
Design validation- Lack of or inadequate procedures
- 21 CFR 820.50Jan 23, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Jan 23, 2025
Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(a)Jan 23, 2025
Production processes
- 21 CFR 820.100(a)Jan 23, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(a)Jan 23, 2025
Lack of or inadequate complaint procedures
- 21 CFR 820.250(b)Jan 23, 2025
Sampling plans
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.