FDA Inspection
Amarin Pharma Inc.Amarin Pharma Inc. – FDA Inspection, Sep 9, 2014
Record Details
This FDA Inspection record concerns Amarin Pharma Inc., with an inspection on September 9, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Amarin Pharma Inc.
- Inspection Date
- September 9, 2014
- Product Type
- Drugs
View Company Profile
ID · c337313d-d9e6-4330-adeb-c63f6f86af67
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 891859
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 314.80(b)Failure to review ADE information
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 314.80(e)(2)Failure to identify post marketing study reports
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of Amarin Pharma Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 29, 2013 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Amarin Pharma Inc.
- FDA Inspection 1100373 - 2019-08-02
- FDA Inspection 854226 - 2013-10-29
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