FDA Inspection 984311 — Addison Biological Laboratory Inc
The FDA completed an inspection of Addison Biological Laboratory Inc on Aug 19, 2016 in Fayette, MO. 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). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 19, 2016
- Fiscal Year
- 2016
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Fayette, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |