813599
Advance Pharmaceutical Inc — FEI 2434807
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 11, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Holtsville, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1396 | 21 CFR 211.42(c)(2) | Rejected Material Area |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1818 | 21 CFR 211.84(c)(2) | Appropriate Opening of Component Containers |
| 1824 | 21 CFR 211.84(c)(5) | Identifying Sample Containers |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |