FDA Inspection
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC.TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC. – FDA Inspection, Nov 23, 2023
Record Details
This FDA Inspection record concerns TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC., with an inspection on November 23, 2023, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 23, 2023
- Product Type
- Devices
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ID · ff14b13a-a495-4d29-bea1-7eddf13bfa80
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1224127
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
19- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - documentation
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