FDA Inspection 907095 — Nordmark Pharma GmbH
The FDA completed an inspection of Nordmark Pharma GmbH on November 20, 2014 in Uetersen. 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
- November 20, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Uetersen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 2032 | 21 CFR 211.194(b) | Test method modification records not maintained |