FDA Inspection
Mylan TeorantaMylan Teoranta – FDA Inspection, May 27, 2014
Record Details
This FDA Inspection record concerns Mylan Teoranta, with an inspection on May 27, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Mylan Teoranta
- Inspection Date
- May 27, 2014
- Product Type
- Drugs
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ID · b043bac6-5e98-4334-9237-2d1fd03c5f93
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 886146
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of Mylan Teoranta
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 22, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 16, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 15, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 30, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mylan Teoranta
- FDA Inspection 1202025 - 2022-07-15
- FDA Inspection 1123541 - 2018-06-22
- FDA Inspection 1041657 - 2018-02-16
- FDA Inspection 978312 - 2016-06-15
- FDA Inspection 782346 - 2012-03-30
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