FDA Inspection 1045598 — Tomita Pharmaceutical Co., Ltd.
The FDA completed an inspection of Tomita Pharmaceutical Co., Ltd. on Mar 9, 2018 in Naruto. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 9, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Naruto (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |