FDA Inspection
Mylan Laboratories LimitedMylan Laboratories Limited – FDA Inspection, May 24, 2019
Record Details
This FDA Inspection record concerns Mylan Laboratories Limited, with an inspection on May 24, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 5c6faee2-8fff-48be-ad53-2d410a6c4e8f
Inspection Facts
- Inspection number
- 1092165
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
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Other FDA inspections of Mylan Laboratories Limited
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 22, 2024 | Not classified | Office of Inspections and Investigations | |
| May 17, 2024 | VAI | Drug Quality Assurance | |
| September 17, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 15, 2017 | Not classified | Office of Inspections and Investigations | New Drug Evaluation |
| September 13, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mylan Laboratories Limited
- FDA Inspection 1255516 - 2024-10-22
- FDA Inspection 1237801 - 2024-05-17
- FDA Inspection 1152889 - 2021-09-17
- FDA Inspection 1016064 - 2017-05-15
- FDA Inspection 852088 - 2013-09-13
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