1084054
InvaDerm, Inc. — FEI 3010165760
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 26, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Somerset, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |