FDA Inspection
Avadel Legacy Pharmaceuticals LLCAvadel Legacy Pharmaceuticals LLC – FDA Inspection, Sep 23, 2015
Record Details
This FDA Inspection record concerns Avadel Legacy Pharmaceuticals LLC, with an inspection on September 23, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 23, 2015
- Product Type
- Drugs
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ID · 4d1c3786-cba8-4f1a-9d8e-be287153e030
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 946968
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
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Other FDA inspections of Avadel Legacy Pharmaceuticals LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 24, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 11, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 6, 2017 | NAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
| December 9, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 2, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Avadel Legacy Pharmaceuticals LLC
- FDA Inspection 1091059 - 2019-04-24
- FDA Inspection 1068774 - 2018-10-11
- FDA Inspection 1027967 - 2017-10-06
- FDA Inspection 859453 - 2013-12-09
- FDA Inspection 762688 - 2011-11-02
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