FDA Inspection 909929 — Evonik Operations GmbH
The FDA completed an inspection of Evonik Operations GmbH on Dec 12, 2014 in Marl. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 12, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Marl (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |