FDA Inspection
Mylan Laboratories Limited (FDF-2)Mylan Laboratories Limited (FDF-2) – FDA Inspection, Aug 25, 2026
Record Details
This FDA Inspection record concerns Mylan Laboratories Limited (FDF-2), with an inspection on August 25, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 044bf8fc-75bd-4ca3-b2b5-efcd94e3ff60
Inspection Facts
- Inspection number
- 1330890
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Mylan Laboratories Limited (FDF-2)
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 3, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 28, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 26, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 26, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 16, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mylan Laboratories Limited (FDF-2)
- FDA Inspection 1253435 - 2023-02-03
- FDA Inspection 1122884 - 2020-02-28
- FDA Inspection 1091217 - 2019-04-26
- FDA Inspection 1012796 - 2017-05-26
- FDA Inspection 884211 - 2014-05-16
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