FDA Inspection
Altaire Pharmaceuticals, Inc.Altaire Pharmaceuticals, Inc. – FDA Inspection, Feb 4, 2010
Record Details
This FDA Inspection record concerns Altaire Pharmaceuticals, Inc., with an inspection on February 4, 2010, issued by the Center for Veterinary Medicine, covering veterinary.
- Inspection Date
- February 4, 2010
- Product Type
- Veterinary
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ID · 10de5794-fee7-413e-ab18-4bd33db4a599
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 641921
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
13- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.165(e)Test methods
Showing 10 of 13 citations.
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Other FDA inspections of Altaire Pharmaceuticals, Inc.
13| Date | Classification | Office | Project area |
|---|---|---|---|
| April 21, 2026 | Not classified | New York District Office | Drug Quality Assurance |
| October 21, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 11, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 19, 2019 | OAI | Center for Veterinary Medicine | Generic Drug Evaluation |
| March 9, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Altaire Pharmaceuticals, Inc.
- FDA Inspection 1314330 - 2026-04-21
- FDA Inspection 1251507 - 2024-10-21
- FDA Inspection 1162640 - 2022-02-11
- FDA Inspection 1089315 - 2019-04-19
- FDA Inspection 1005208 - 2017-03-09
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