FDA Inspection 926688 — Mentholatum (China) Pharmaceuticals Co., Ltd.
The FDA completed an inspection of Mentholatum (China) Pharmaceuticals Co., Ltd. on Apr 10, 2015 in Zhongshan. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 10, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Zhongshan (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |