FDA Inspection 1028353 — Lotus Pharmaceutical Co., Ltd.
The FDA completed an inspection of Lotus Pharmaceutical Co., Ltd. on Sep 22, 2017 in Nan Tou Xian. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 22, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Nan Tou Xian (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |