FDA Inspection
Altaire Pharmaceuticals, Inc.Altaire Pharmaceuticals, Inc. – FDA Inspection, Mar 19, 2012
Record Details
This FDA Inspection record concerns Altaire Pharmaceuticals, Inc., with an inspection on March 19, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 19, 2012
- Product Type
- Drugs
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ID · f974de5b-1ab5-4777-99fc-699c1aff0b56
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 772796
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
10- 21 CFR 211.198(a)Quality Control Review
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.130(a)Prevention of cross contamination, mix-ups
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.80(a)Written Procedures Not Followed
- 21 CFR 111.325(a)Laboratory operations: electronic
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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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