FDA Inspection
TERUMO VIETNAM CO., LTDTERUMO VIETNAM CO., LTD – FDA Inspection, Aug 8, 2024
Record Details
This FDA Inspection record concerns TERUMO VIETNAM CO., LTD, with an inspection on August 8, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · e41524d1-cb38-4dfc-b768-77e405f8bfb9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1246179
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.40Lack of procedures, or not maintained
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