FDA Inspection
Terumo Corporation Fujinomiya FactoryTerumo Corporation Fujinomiya Factory – FDA Inspection, May 19, 2023
Record Details
This FDA Inspection record concerns Terumo Corporation Fujinomiya Factory, with an inspection on May 19, 2023, issued by the Office of Inspections and Investigations.
- Inspection Date
- May 19, 2023
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ID · ffea153e-044e-4781-af5e-1368ccfe4295
Inspection Facts
- Inspection number
- 1206261
- FDA center
- Biologics
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.101(d)Verification of component addition
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.80(a)Written Procedures Not Followed
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Other FDA inspections of Terumo Corporation Fujinomiya Factory
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 1004817 - 2017-02-07
- FDA Inspection 875358 - 2014-03-20
- FDA Inspection 746978 - 2011-09-16
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