FDA Inspection
Terumo Corporation Fujinomiya FactoryTerumo Corporation Fujinomiya Factory – FDA Inspection, Feb 7, 2017
Record Details
This FDA Inspection record concerns Terumo Corporation Fujinomiya Factory, with an inspection on February 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Angela E. Glenn (Issuing Officer)
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ID · e4ec0ca3-41ef-46be-ab3a-96093ca6bbc7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1004817
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Terumo Corporation Fujinomiya Factory
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2023 | Not classified | Office of Inspections and Investigations | |
| March 20, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 16, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Terumo Corporation Fujinomiya Factory
- FDA Inspection 1206261 - 2023-05-19
- FDA Inspection 875358 - 2014-03-20
- FDA Inspection 746978 - 2011-09-16
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