FDA Inspection 1066669 — Catalent Germany Schorndorf GmbH
The FDA completed an inspection of Catalent Germany Schorndorf GmbH on September 21, 2018 in Schorndorf. 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
- September 21, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Schorndorf (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 2017 | 21 CFR 211.188(b)(5) | In-Process and Laboratory Control Results |