FDA Inspection 836631 — Losan Pharma GmbH
The FDA completed an inspection of Losan Pharma GmbH on June 20, 2013 in Neuenburg Am Rhein. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 20, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Neuenburg Am Rhein (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |