FDA Inspection 1024786 — Nang Kuang Pharmaceutical Co., Ltd.
The FDA completed an inspection of Nang Kuang Pharmaceutical Co., Ltd. on Sep 5, 2017 in Tai Nan Shi. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 5, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tai Nan Shi (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |