Mylan Pharmaceuticals, Inc.
FDA inspection history across 2 sites, 2018 to 2020
- 1
- Close-out
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2018: one Form 483; 2020: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–20One Form 483 and one close-out letter, at Morgantown, West Virginia and Canonsburg, Pennsylvania.
Cited most
Across all Mylan Pharmaceuticals observations on file
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.192Production record review2
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.160General requirements1
The complete Mylan Pharmaceuticals file.
All 2 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 · 2020
Latest: Close-out, May 11, 2020 →Morgantown, West Virginia
One Form 483 · 2018 · 13 observations
Latest: Form 483, Apr 12, 2018 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-05-11 | Close-out Close-out letter | Canonsburg, Pennsylvania | — | $99 |
| 2018-04-12 | 483 Form 483 | Morgantown, West Virginia | 13 | $99 |
Investigators on these documents
Alison N. Stieg (1)Atul J. Agrawal (1)Ileana Barreto-Pettit (1)James M. Mason (1)Ko U. Min (1)Marcus A. Ray (1)Melissa T. Roy (1)Rebecca E. Dombrowski (1)
FEI number 1110315 · most recent document May 11, 2020
About Mylan Pharmaceuticals, Inc.
How many FDA Form 483s has Mylan Pharmaceuticals, Inc. received?
FDA Intel has 1 Form 483 on file for Mylan Pharmaceuticals, Inc.; the most recent is dated Apr 12, 2018.
When was Mylan Pharmaceuticals, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Mylan Pharmaceuticals, Inc. is a Form 483 dated Apr 12, 2018, for the site in Morgantown, West Virginia.
What did FDA cite at Mylan Pharmaceuticals, Inc.?
The regulations cited most in the observations on file for Mylan Pharmaceuticals, Inc. are 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.192 (Production record review), 2 times.