FDA Inspection 1039841 — Solupharm Pharmazeutische Erzeugnisse Gmbh
The FDA completed an inspection of Solupharm Pharmazeutische Erzeugnisse Gmbh on Feb 2, 2018 in Melsungen. 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
- Feb 2, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Melsungen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |