FDA Inspection 925316 — Dalian Goodwood Medical Care Ltd
The FDA completed an inspection of Dalian Goodwood Medical Care Ltd on Apr 17, 2015 in Dalian. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 17, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dalian (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |