FDA Inspection
Mylan Laboratories LimitedMylan Laboratories Limited – FDA Inspection, May 27, 2022
Record Details
This FDA Inspection record concerns Mylan Laboratories Limited, with an inspection on May 27, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Mylan Laboratories Limited
- Inspection Date
- May 27, 2022
- Product Type
- Drugs
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ID · 6dfb912f-230c-40b6-9b14-b75fac5bc4ca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1170427
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.160(b)(2)In-process sample representation/identification
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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Other FDA inspections of Mylan Laboratories Limited
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2023 | Not classified | Office of Inspections and Investigations | |
| August 27, 2019 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| April 4, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 13, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 3, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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