FDA Inspection 784610 — Rohto-Mentholatum (Vietnam) Co., Ltd.
The FDA completed an inspection of Rohto-Mentholatum (Vietnam) Co., Ltd. on May 15, 2012 in Ho Chi Minh. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 15, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ho Chi Minh (Vietnam)
Citations
| ID | CFR | Description |
|---|---|---|
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1768 | 21 CFR 211.137(b) | Storage conditions |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1823 | 21 CFR 211.84(c)(4) | Top/Middle/Bottom container sampling |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3609 | 21 CFR 211.160(b)(2) | In-process sample representation/identification |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |
| 4412 | 21 CFR 211.194(a)(7) | Signatures and dates--person who performs test |