Drug factory · FDA FEI 3002808337
Terumo Corporation
818, Misonodaira, Fujinomiya-City, Japan
Problems found, fixed voluntarily at FDA's last inspection, Feb 7, 2017.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2011: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Anticoagulant Citrate Phosphate Dextrose (cpd) Solution and Adsol Preservation S | Makes it, tests it, labels it and sterilizes it | Terumo Corporation | 53877-006, 53877-008, 53877-009 +3 |
| Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) | Makes it, tests it, packages it, labels it and sterilizes it | Terumo Corporation | 53877-001, 53877-108, 53877-109 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 7, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Mar 20, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 16, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 7, 2017 inspection
- Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.