Mylan LLC
FDA inspection history in Caguas, Puerto Rico, 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 Caguas, Puerto Rico.
Cited most
Across all Mylan observations on file
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Mylan file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Caguas, Puerto Rico
One Form 483 · 2015 · 4 observations
Latest: Form 483, May 22, 2015 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-05-22 | 483 Form 483 | Caguas, Puerto Rico | 4 | $99 |
Investigators on these documents
FEI number 2650176 · most recent document May 22, 2015
About Mylan LLC
How many FDA Form 483s has Mylan LLC received?
FDA Intel has 1 Form 483 on file for Mylan LLC; the most recent is dated May 22, 2015.
When was Mylan LLC last inspected by FDA?
The most recent FDA inspection document on file for Mylan LLC is a Form 483 dated May 22, 2015, for the site in Caguas, Puerto Rico.
What did FDA cite at Mylan LLC?
The regulations cited most in the observations on file for Mylan LLC are 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 1 time.