FDA Inspection 1017139 — Advance Pharmaceutical Inc
The FDA completed an inspection of Advance Pharmaceutical Inc on July 6, 2017 in Holtsville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 6, 2017
- Fiscal Year
- 2017
- 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 |
| 2017 | 21 CFR 211.188(b)(5) | In-Process and Laboratory Control Results |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3588 | 21 CFR 211.110(a)(3) | Mixing adequacy |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |