FDA Inspection 1159191 — Vitti Labs, LLC
The FDA completed an inspection of Vitti Labs, LLC on December 20, 2021 in Liberty, MO. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 20, 2021
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Liberty, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |