FDA Inspection 1102979 — Lyocontract GmbH
The FDA completed an inspection of Lyocontract GmbH on September 20, 2019 in Ilsenburg (Harz). The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 20, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ilsenburg (Harz) (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |