FDA Inspection 1200356 — TERUMO CORPORATION
The FDA completed an inspection of TERUMO CORPORATION on Mar 21, 2023 in Nakakoma-Gun. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 21, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Nakakoma-Gun (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1163 | 21 CFR 211.28(b) | Habits of good sanitation & health |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 21295 | 21 CFR 211.110(b) | In-process conformity - examination, sample testing |
| 3550 | 21 CFR 211.46(c) | Exhaust systems inadequate to control air contamination |