FDA Inspection 756490 — Advance Pharmaceutical Inc
The FDA completed an inspection of Advance Pharmaceutical Inc on December 9, 2011 in Holtsville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 9, 2011
- Fiscal Year
- 2012
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Holtsville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 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 |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4309 | 21 CFR 211.84(c)(2) | Containers sampled so as to prevent contamination |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |