FDA Inspection
Alkermes, Inc.Alkermes, Inc. – FDA Inspection, Sep 29, 2009
Record Details
This FDA Inspection record concerns Alkermes, Inc., with an inspection on September 29, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Alkermes, Inc.
- Inspection Date
- September 29, 2009
- Product Type
- Drugs
View Company Profile
ID · a56842a6-c87e-407e-bc6c-c7f4058c4796
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 615049
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 310.305(c)(2)Submission of report follow-up
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
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Other FDA inspections of Alkermes, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 28, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 12, 2013 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 15, 2012 | NAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
Other documents for Alkermes, Inc.
- FDA Inspection 933726 - 2015-05-28
- FDA Inspection 859795 - 2013-12-12
- FDA Inspection 790639 - 2012-06-15
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