FDA Inspection
Ipsen Bioscience, Inc.Ipsen Bioscience, Inc. – FDA Inspection, Feb 26, 2019
Record Details
This FDA Inspection record concerns Ipsen Bioscience, Inc., with an inspection on February 26, 2019, issued by the New England District Office, covering human drugs.
- Person
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ID · 4f32d07c-8374-4664-8b27-d5f32643083a
Inspection Facts
- Inspection number
- 1080531
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
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Other FDA inspections of Ipsen Bioscience, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 20, 2025 | Not classified | New England District Office | |
| December 5, 2017 | OAI | New England District Office | Generic Drug Evaluation |
| July 17, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ipsen Bioscience, Inc.
- FDA Inspection 1270829 - 2025-05-20
- FDA Inspection 1034205 - 2017-12-05
- FDA Inspection 940914 - 2015-07-17
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