FDA Inspection
Mylan Laboratories LimitedMylan Laboratories Limited – FDA Inspection, May 15, 2017
Record Details
This FDA Inspection record concerns Mylan Laboratories Limited, with an inspection on May 15, 2017, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · d7f90cbe-0b68-40ee-9fc9-fa25762d773f
Inspection Facts
- Inspection number
- 1016064
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.52Washing and toilet facilities are deficient
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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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 24, 2019 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| 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 1092165 - 2019-05-24
- FDA Inspection 852088 - 2013-09-13
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