Mylan Laboratories Limited
FDA inspection history across 2 sites, 2015 to 2022
- 1
- Form 483
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2015: one warning letter; 2017: one close-out letter; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17One warning letter and one close-out letter, at Canonsburg, Pennsylvania.
- 2022One Form 483, at Bangalore, India.
Cited most
Across all Mylan Laboratories Limited observations on file
- 21 CFR 211.160General requirements2
The complete Mylan Laboratories Limited file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Canonsburg, Pennsylvania
One close-out letter and one warning letter · 2015 to 2017
Latest: Close-out, Jul 24, 2017 →Bangalore, India
One Form 483 · 2022 · 2 observations
Latest: Form 483, May 27, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-05-27 | 483 Form 483 | Bangalore, India | 2 | $99 |
| 2017-07-24 | Close-out Close-out letter | Canonsburg, Pennsylvania | — | $99 |
| 2015-08-06 | Warning letter Warning letter | Canonsburg, Pennsylvania | — | $99 |
Investigators on these documents
FEI number 3007512701 · most recent document May 27, 2022
About Mylan Laboratories Limited
How many FDA Form 483s has Mylan Laboratories Limited received?
FDA Intel has 1 Form 483 on file for Mylan Laboratories Limited; the most recent is dated May 27, 2022.
When was Mylan Laboratories Limited last inspected by FDA?
The most recent FDA inspection document on file for Mylan Laboratories Limited is a Form 483 dated May 27, 2022, for the site in Bangalore, India.
What did FDA cite at Mylan Laboratories Limited?
The regulations cited most in the observations on file for Mylan Laboratories Limited are 21 CFR 211.160 (General requirements), 2 times.
Has Mylan Laboratories Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Mylan Laboratories Limited; the most recent is dated Aug 6, 2015.