FDA Inspection 1039842 — Wasserburger Arzneimittelwerk GmbH
The FDA completed an inspection of Wasserburger Arzneimittelwerk GmbH on Jan 23, 2018 in Wasserburg a. Inn. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 23, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wasserburg a. Inn (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |