FDA Inspection
Mylan Laboratories LimitedMylan Laboratories Limited – FDA Inspection, May 24, 2024
Record Details
This FDA Inspection record concerns Mylan Laboratories Limited, with an inspection on May 24, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · eff4ccfb-5f0a-4b77-a91e-fe274e65f52a
Inspection Facts
- Inspection number
- 1238860
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.167(c)Controlled release test methods written, followed
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Mylan Laboratories Limited
8| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 18, 2019 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| April 12, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 14, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 25, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mylan Laboratories Limited
- FDA Inspection 1117137 - 2020-02-07
- FDA Inspection 1076887 - 2019-01-18
- FDA Inspection 1050962 - 2018-04-12
- FDA Inspection 986244 - 2016-09-14
- FDA Inspection 920472 - 2015-03-25
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