FDA Inspection
Mylan Technologies, Inc.Mylan Technologies, Inc. – FDA Inspection, Sep 14, 2017
Record Details
This FDA Inspection record concerns Mylan Technologies, Inc., with an inspection on September 14, 2017, issued by the New England District Office, covering human drugs.
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ID · 1626456b-8b63-4491-a40b-496bc50eb84d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1026374
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.165(e)Test methods
- 21 CFR 820.30(a)Design control - no procedures
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Other FDA inspections of Mylan Technologies, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| October 21, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 18, 2023 | Not classified | New England District Office | |
| November 20, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 15, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 13, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mylan Technologies, Inc.
- FDA Inspection 1285894 - 2025-10-21
- FDA Inspection 1226467 - 2023-12-18
- FDA Inspection 1133997 - 2020-11-20
- FDA Inspection 1065833 - 2018-08-15
- FDA Inspection 970691 - 2016-04-13
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