FDA Inspection 917312 — Quality Animal Care Mfg Inc
The FDA completed an inspection of Quality Animal Care Mfg Inc on March 25, 2015 in Lincoln, NE. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 25, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lincoln, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 4324 | 21 CFR 211.110(b) | In-process materials specifications testing |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4576 | 21 CFR 211.192 | No written record of investigation |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |