FDA Inspection
KOFU FACTORY OF TERUMO CORP.KOFU FACTORY OF TERUMO CORP. – FDA Inspection, Jul 25, 2018
Record Details
This FDA Inspection record concerns KOFU FACTORY OF TERUMO CORP., with an inspection on July 25, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · d25f97bf-ba81-4b08-bd98-17ba6a3a5900
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1061387
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.25(a)Training , Education , Experience overall
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Other FDA inspections of KOFU FACTORY OF TERUMO CORP.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2024 | Not classified | Office of Inspections and Investigations | |
| March 21, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 1, 2018 | Not classified | Office of Inspections and Investigations | |
| February 5, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 17, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for KOFU FACTORY OF TERUMO CORP.
- FDA Inspection 1287452 - 2024-12-13
- FDA Inspection 1200356 - 2023-03-21
- FDA Inspection 1063138 - 2018-08-01
- FDA Inspection 959252 - 2016-02-05
- FDA Inspection 877631 - 2014-04-17
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