656460
Best Formulations LLC — FEI 3003121131
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 2, 2010
- Fiscal Year
- 2010
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- City Of Industry, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 15473 | 21 CFR 111.20(c)(7) | Physical plant - separate areas - holding |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15954 | 21 CFR 111.113(a)(2) | Quality control master manufacturing record; material review, disposition |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |