FDA Inspection
Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc. – FDA Inspection, Jul 17, 2015
Record Details
This FDA Inspection record concerns Mylan Pharmaceuticals Inc., with an inspection on July 17, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Mylan Pharmaceuticals Inc.
- Inspection Date
- July 17, 2015
- Product Type
- Drugs
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ID · 252a64f1-2dd4-4f8b-954b-5c761352260d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 937344
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.166(a)(4)Testing in same container - closure system
- 21 CFR 211.166(a)(2)Stability sample storage conditions described
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Other FDA inspections of Mylan Pharmaceuticals Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 22, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2017 | VAI | San Francisco District Office | New Drug Evaluation |
| October 14, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 4, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 27, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mylan Pharmaceuticals Inc.
- FDA Inspection 1132054 - 2020-09-22
- FDA Inspection 1031174 - 2017-11-09
- FDA Inspection 990174 - 2016-10-14
- FDA Inspection 894744 - 2014-09-04
- FDA Inspection 799168 - 2012-09-27
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