FDA Inspection
Mylan Specialty, L.P.Mylan Specialty, L.P. – FDA Inspection, Jan 14, 2011
Record Details
This FDA Inspection record concerns Mylan Specialty, L.P., with an inspection on January 14, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Mylan Specialty, L.P.
- Inspection Date
- January 14, 2011
- Product Type
- Drugs
View Company Profile
ID · 1d97ddfd-c751-44b3-9796-408bae2938a6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 707604
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.194(a)(8)Second person sign off
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Other FDA inspections of Mylan Specialty, L.P.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 22, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 16, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 25, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 11, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mylan Specialty, L.P.
- FDA Inspection 833616 - 2013-05-23
- FDA Inspection 828428 - 2013-04-22
- FDA Inspection 770930 - 2012-02-16
- FDA Inspection 711403 - 2011-02-25
- FDA Inspection 662822 - 2010-05-11
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