FDA Inspection
Ipsen Bioscience, Inc.Ipsen Bioscience, Inc. – FDA Inspection, Dec 5, 2017
Record Details
This FDA Inspection record concerns Ipsen Bioscience, Inc., with an inspection on December 5, 2017, issued by the New England District Office, covering human drugs.
- People
- Delaram Moshkelani (Issuing Officer)
- Robert J. Martin
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ID · a3162201-ae4c-49f9-b2ed-0aae5a9160e7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1034205
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.84(d)(3)Certificates of Testing (Containers, Closures)
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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 | |
| February 26, 2019 | Not classified | New England District Office | Drug Quality Assurance |
| 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 1080531 - 2019-02-26
- FDA Inspection 940914 - 2015-07-17
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