FDA Inspection 1066250 — SPARMED
The FDA completed an inspection of SPARMED on Sep 21, 2018 in Farum. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 21, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Farum (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 1845 | 21 CFR 211.84(d)(3) | Container/Closure Written Test Procedure |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |