FDA Inspection 1005208 — Altaire Pharmaceuticals, Inc.
The FDA completed an inspection of Altaire Pharmaceuticals, Inc. on Mar 9, 2017 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
- Mar 9, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Aquebogue, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4388 | 21 CFR 211.198(a) | Complaints reviewed by Quality Control Unit |