FDA Inspection
Mylan Laboratories LimitedMylan Laboratories Limited – FDA Inspection, Aug 27, 2019
Record Details
This FDA Inspection record concerns Mylan Laboratories Limited, with an inspection on August 27, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 2335e013-3791-4343-b67b-903e0fe4ce88
Inspection Facts
- Inspection number
- 1100697
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 | |
| May 27, 2022 | VAI | Center for Drug Evaluation and Research | 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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