FDA Inspection 759369 — Aesica Pharmaceutical GmbH
The FDA completed an inspection of Aesica Pharmaceutical GmbH on Nov 11, 2011 in Monheim am Rhein. 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). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 11, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Monheim am Rhein (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |