Taiwan Aulisa Medical Devices Technologies, Inc.
6F-2, No. 3-1, YuanQu St., Nangang Dist., Taipei City, TW
Registered product codes
6 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 3014856521.
FDA inspections
2 on file
- Official Action Indicated (OAI)Nov 23, 2023
Compliance: Devices · Citations posted
- Official Action Indicated (OAI)Nov 23, 2023
Postmarket Assurance: Devices · Citations posted
Inspection citations
10 on file
Top cited requirements
Compare to industry ↗21 CFR 820.184DHR - not or inadequately maintained
221 CFR 820.22Quality audits - auditor independence
121 CFR 820.25(b)Training - Lack of or inadequate procedures
121 CFR 820.30(d)Design output - documentation
121 CFR 820.30(f)Design verification - documentation
121 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
1
- 21 CFR 820.22Nov 23, 2023
Quality audits - auditor independence
- 21 CFR 820.25(b)Nov 23, 2023
Training - Lack of or inadequate procedures
- 21 CFR 820.30(d)Nov 23, 2023
Design output - documentation
- 21 CFR 820.30(f)Nov 23, 2023
Design verification - documentation
- 21 CFR 820.30(i)Nov 23, 2023
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.72(a)Nov 23, 2023
Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.100(a)Nov 23, 2023
Lack of or inadequate procedures
- 21 CFR 820.184Nov 23, 2023
DHR - not or inadequately maintained
- 21 CFR 820.184Nov 23, 2023
Lack of or inadequate DHR procedures
- 21 CFR 820.250(b)Nov 23, 2023
Sampling methods - 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.