FDA Inspection 583183 — Addison Biological Laboratory Inc
The FDA completed an inspection of Addison Biological Laboratory Inc on May 14, 2009 in Fayette, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 14, 2009
- Fiscal Year
- 2009
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Fayette, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1791 | 21 CFR 211.80(c) | Storage off Floor, Spaced Suitably |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |