Mylan Laboratories Limited
FDA inspection history in Hosur, India, 2021 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–24Three Form 483s, at Hosur, India.
- 2022The longest 483 on file: 6 observations over 8 pages at Hosur, India.
Cited most
Across all Mylan Laboratories Limited observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
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
Hosur, India
Three Form 483s · 2021 to 2024 · 16 observations
Latest: Form 483, May 17, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-17 | 483 Form 483 | Hosur, India | 5 | $99 |
| 2022-09-23 | 483 Form 483 | Hosur, India | 6 | $99 |
| 2021-09-17 | 483 Form 483 | Hosur, India | 5 | $99 |
Investigators on these documents
Kevin P. Regan (1)Patty P. Kaewussdangkul (1)Rita K. Kabaso (1)Thomas J. Arista (1)
FEI number 3008255419 · most recent document May 17, 2024
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 17, 2024.
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 17, 2024, for the site in Hosur, 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 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.42 (Design and construction features), 4 times; 21 CFR 211.160 (General requirements), 1 time.