FDA Inspection
Mylan Laboratories LimitedMylan Laboratories Limited – FDA Inspection, Sep 17, 2021
Record Details
This FDA Inspection record concerns Mylan Laboratories Limited, with an inspection on September 17, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Mylan Laboratories Limited
- Inspection Date
- September 17, 2021
- Product Type
- Drugs
View Company Profile
ID · a21e3e50-fda9-4f0f-bdc3-9dd0ee43158d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1152889
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.113(b)Validation lacking for sterile drug products
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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 | |
| May 24, 2019 | Not classified | Office of Inspections and Investigations | 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 1092165 - 2019-05-24
- FDA Inspection 1016064 - 2017-05-15
- FDA Inspection 852088 - 2013-09-13
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