Mylan Laboratories Limited
FDA inspection history across 3 sites, 2016 to 2026
- 3
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2016: one Form 483; 2017: one warning letter; 2018: one close-out letter; 2024: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–18One Form 483, one warning letter and one close-out letter, at Sinnar, India and Canonsburg, Pennsylvania.
- 2024–26Two Form 483s, at Nashik, India and Sinnar, India.
- 2024The longest 483 on file: 7 observations over 15 pages at Nashik, India.
Cited most
Across all Mylan Laboratories Limited observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.160General requirements1
- 21 CFR 211.165(e)Testing and release for distribution1
- 21 CFR 211.180General requirements1
The complete Mylan Laboratories Limited file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Sinnar, India
Two Form 483s · 2016 to 2026 · 2 observations
Latest: Form 483, May 15, 2026 →Canonsburg, Pennsylvania
One close-out letter and one warning letter · 2017 to 2018
Latest: Close-out, Jul 18, 2018 →Nashik, India
One Form 483 · 2024 · 7 observations
Latest: Form 483, May 24, 2024 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-05-15 | 483 Form 483 | Sinnar, India | 1 | $99 |
| 2024-05-24 | 483 Form 483 | Nashik, India | 7 | $99 |
| 2018-07-18 | Close-out Close-out letter | Canonsburg, Pennsylvania | — | $99 |
| 2017-04-03 | Warning letter Warning letter | Canonsburg, Pennsylvania | — | $99 |
| 2016-09-14 | 483 Form 483 | Sinnar, India | 1 | $99 |
Investigators on these documents
Arsen Karapetyan (1)Massoud Motamed (1)Pratik S. Upadhyay (1)Unnee Ranjan (1)Wayne D. McGrath (1)
FEI number 3005587313 · most recent document May 15, 2026
About Mylan Laboratories Limited
How many FDA Form 483s has Mylan Laboratories Limited received?
FDA Intel has 3 Form 483s on file for Mylan Laboratories Limited; the most recent is dated May 15, 2026.
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 15, 2026, for the site in Sinnar, 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 211.192 (Production record review), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.160 (General requirements), 1 time.
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 Apr 3, 2017.