FDA Inspection
Mylan Specialty, L.P.Mylan Specialty, L.P. – FDA Inspection, May 23, 2013
Record Details
This FDA Inspection record concerns Mylan Specialty, L.P., with an inspection on May 23, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Mylan Specialty, L.P.
- Inspection Date
- May 23, 2013
- Product Type
- Drugs
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ID · 1f49fe8e-dc02-4f0b-b1aa-e40a1846c8a3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 833616
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.198(a)Complaint Handling Procedure
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Other FDA inspections of Mylan Specialty, L.P.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| January 14, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 11, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mylan Specialty, L.P.
- FDA Inspection 828428 - 2013-04-22
- FDA Inspection 770930 - 2012-02-16
- FDA Inspection 711403 - 2011-02-25
- FDA Inspection 707604 - 2011-01-14
- FDA Inspection 662822 - 2010-05-11
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