FDA Inspection
Altaire Pharmaceuticals, Inc.Altaire Pharmaceuticals, Inc. – FDA Inspection, Apr 19, 2019
Record Details
This FDA Inspection record concerns Altaire Pharmaceuticals, Inc., with an inspection on April 19, 2019, issued by the Center for Veterinary Medicine, covering veterinary.
- People
- Avital A. Shimanovich (Issuing Officer)
- Bijoy Panicker
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ID · b7371309-8de4-43de-bec3-fb911cfa0240
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1089315
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
21- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(1)Sampling and testing procedures described
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.188(a)Accurate reproduction
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training , Education , Experience overall
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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 |
| March 9, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| December 15, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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 1005208 - 2017-03-09
- FDA Inspection 955795 - 2015-12-15
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