FDA Inspection 906095 — Rohto Pharmaceutical Co., Ltd. (Ueno Plant)
The FDA completed an inspection of Rohto Pharmaceutical Co., Ltd. (Ueno Plant) on Nov 14, 2014 in Iga. 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). 10 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 14, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Iga (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1630 | 21 CFR 211.130(b) | Unlabeled filled containers controls |
| 1722 | 21 CFR 211.134(a) | Correct labels during finishing operations |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4344 | 21 CFR 211.160(b)(1) | Sampling and testing procedures described |