FDA Inspection 955795 — Altaire Pharmaceuticals, Inc.
The FDA completed an inspection of Altaire Pharmaceuticals, Inc. on Dec 15, 2015 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 15, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Aquebogue, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |