FDA Inspection 785402 — Altaire Pharmaceuticals, Inc.
The FDA completed an inspection of Altaire Pharmaceuticals, Inc. on Jun 7, 2012 in Aquebogue, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 7, 2012
- Fiscal Year
- 2012
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Aquebogue, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |