FDA Inspection 871578 — Sever Pharma Solutions
The FDA completed an inspection of Sever Pharma Solutions on March 27, 2014 in Malmo. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 27, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Malmo (Sweden)
Citations
| ID | CFR | Description |
|---|---|---|
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |