FDA Inspection 1102220 — DermaPharm A/S
The FDA completed an inspection of DermaPharm A/S on September 19, 2019 in Farup. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 19, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Farup (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2404 | 21 CFR 211.194(a)(6) | Comparison of Test Results to Specifications |
| 4576 | 21 CFR 211.192 | No written record of investigation |