FDA Inspection
Terumo Clinical Supply Co. Ltd.Terumo Clinical Supply Co. Ltd. – FDA Inspection, Jan 26, 2018
Record Details
This FDA Inspection record concerns Terumo Clinical Supply Co. Ltd., with an inspection on January 26, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- January 26, 2018
- Product Type
- Medical Devices & Rad Health
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ID · 412c7a5b-a0f3-45a2-837d-28339a02131d
Inspection Facts
- Inspection number
- 1044742
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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Other FDA inspections of Terumo Clinical Supply Co. Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2018 | Not classified | Office of Inspections and Investigations |
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