FDA Inspection
Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc. – FDA Inspection, Nov 9, 2017
Record Details
This FDA Inspection record concerns Mylan Pharmaceuticals Inc., with an inspection on November 9, 2017, issued by the San Francisco District Office, covering human drugs.
- People
- Ashar P. Parikh
- Kristin M. Abaonza (FDA Associated Person)
- Yong Hu (Issuing Officer)
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ID · 2c4dead4-ce51-48f0-992f-d44ab3448462
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031174
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.67(b)Written procedures fail to include
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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 |
| October 14, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 17, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 990174 - 2016-10-14
- FDA Inspection 937344 - 2015-07-17
- FDA Inspection 894744 - 2014-09-04
- FDA Inspection 799168 - 2012-09-27
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