Viatris Pharmaceuticals LLC
FDA inspection history in Barceloneta, Puerto Rico, 2013 to 2019
- 3
- Form 483s
Every document, by year
- Form 483
2013: one Form 483; 2015: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–15Two Form 483s, at Barceloneta, Puerto Rico.
- 2013The longest 483 on file: 16 observations over 15 pages at Barceloneta, Puerto Rico.
- 2019One Form 483, at Barceloneta, Puerto Rico.
Cited most
Across all Viatris Pharmaceuticals observations on file
- 21 CFR 211.160(a)General requirements4
- 21 CFR 211.194(a)Laboratory records4
- 21 CFR 211.192Production record review3
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.67(b)Equipment cleaning and maintenance2
The complete Viatris Pharmaceuticals 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
Barceloneta, Puerto Rico
Three Form 483s · 2013 to 2019 · 23 observations
Latest: Form 483, Dec 20, 2019 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-12-20 | 483 Form 483 | Barceloneta, Puerto Rico | 3 | $99 |
| 2015-07-02 | 483 Form 483 | Barceloneta, Puerto Rico | 4 | $99 |
| 2013-08-20 | 483 Form 483 | Barceloneta, Puerto Rico | 16 | $99 |
Investigators on these documents
Noreen Muniz (2)Jose A. Cruz-Gonzalez (1)Moraima J. Ramos-Valle (1)Raquel Gonzalez Rivera (1)Samina S. Khan (1)
FEI number 2627208 · most recent document Dec 20, 2019
About Viatris Pharmaceuticals LLC
How many FDA Form 483s has Viatris Pharmaceuticals LLC received?
FDA Intel has 3 Form 483s on file for Viatris Pharmaceuticals LLC; the most recent is dated Dec 20, 2019.
When was Viatris Pharmaceuticals LLC last inspected by FDA?
The most recent FDA inspection document on file for Viatris Pharmaceuticals LLC is a Form 483 dated Dec 20, 2019, for the site in Barceloneta, Puerto Rico.
What did FDA cite at Viatris Pharmaceuticals LLC?
The regulations cited most in the observations on file for Viatris Pharmaceuticals LLC are 21 CFR 211.160(a) (General requirements), 4 times; 21 CFR 211.194(a) (Laboratory records), 4 times; 21 CFR 211.192 (Production record review), 3 times.