FDA Inspection
Ipsen Pharma BiotechIpsen Pharma Biotech – FDA Inspection, Jun 24, 2014
Record Details
This FDA Inspection record concerns Ipsen Pharma Biotech, with an inspection on June 24, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Ipsen Pharma Biotech
- Inspection Date
- June 24, 2014
- Product Type
- Drugs
View Company Profile
ID · 381e49a5-513d-4ab4-82d4-ad92ab28810e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 886713
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Ipsen Pharma Biotech
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 20, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 29, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 6, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 11, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 12, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ipsen Pharma Biotech
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- FDA Inspection 1154897 - 2020-11-06
- FDA Inspection 1062744 - 2018-06-11
- FDA Inspection 980508 - 2016-07-12
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