FDA Inspection
Altaire Pharmaceuticals, Inc.Altaire Pharmaceuticals, Inc. – FDA Inspection, Jul 29, 2014
Record Details
This FDA Inspection record concerns Altaire Pharmaceuticals, Inc., with an inspection on July 29, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 29, 2014
- Product Type
- Drugs
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ID · efa5b9f9-0125-4bf4-88d6-2d43b5d54a9b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 891028
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.204Returned drug products identified and held
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(a)Written Procedures Not Followed
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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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