Mylan Pharmaceuticals Inc.
FDA inspection history in San Carlos, California, 2015
- 1
- Form 483
Every document, by year
- Form 483
2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at San Carlos, California.
Cited most
Across all Mylan Pharmaceuticals observations on file
- 21 CFR 211.166(a)(2)Stability testing2
- 21 CFR 211.160(b)(4)General requirements1
- 21 CFR 211.170(b)Reserve samples1
- 21 CFR 211.188(b)(8)Batch production and control records1
The complete Mylan Pharmaceuticals file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
San Carlos, California
One Form 483 · 2015 · 5 observations
Latest: Form 483, Jul 17, 2015 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-07-17 | 483 Form 483 | San Carlos, California | 5 | $99 |
Investigators on these documents
Darren S. Brown (1)Lucila B. Nwatu (1)Robert D. Tollefsen (1)
FEI number 3007886374 · most recent document Jul 17, 2015
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 Jul 17, 2015.
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 Jul 17, 2015, for the site in San Carlos, California.
What did FDA cite at Mylan Pharmaceuticals Inc.?
The regulations cited most in the observations on file for Mylan Pharmaceuticals Inc. are 21 CFR 211.166(a)(2) (Stability testing), 2 times; 21 CFR 211.160(b)(4) (General requirements), 1 time; 21 CFR 211.170(b) (Reserve samples), 1 time.