FDA Inspection 1312352 — Rohto-Mentholatum (Vietnam) Co., Ltd.
The FDA completed an inspection of Rohto-Mentholatum (Vietnam) Co., Ltd. on Apr 14, 2026 in Ho Chi Minh. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 14, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ho Chi Minh (Vietnam)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1430 | 21 CFR 211.42(c)(10)(i) | Floors, walls, ceiling surfaces |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |