Viatris, Inc.
FDA inspection history across 3 sites, 2016 to 2024
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2016: one Form 483; 2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Pithampur, India.
- 2024One warning letter and one Form 483, at Canonsburg, Pennsylvania and Pithampur, District Dhar, India.
- 2024The longest 483 on file: 6 observations over 18 pages at Pithampur, District Dhar, India.
Cited most
Across all Viatris observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.103Calculation of yield1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Viatris 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
Canonsburg, Pennsylvania
One warning letter · 2024
Latest: Warning letter, Dec 19, 2024 →Pithampur, District Dhar, India
One Form 483 · 2024 · 6 observations
Latest: Form 483, Jun 26, 2024 →Pithampur, India
One Form 483 · 2016 · 1 observation
Latest: Form 483, Feb 5, 2016 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-19 | Warning letter Warning letter | Canonsburg, Pennsylvania | — | $99 |
| 2024-06-26 | 483 Form 483 | Pithampur, District Dhar, India | 6 | $99 |
| 2016-02-05 | 483 Form 483 | Pithampur, India | 1 | $99 |
Investigators on these documents
Ariel Cruz Figueroa (1)Pratik S. Upadhyay (1)Steven A. Brettler (1)
FEI number 3010453141 · most recent document Dec 19, 2024
About Viatris, Inc.
How many FDA Form 483s has Viatris, Inc. received?
FDA Intel has 2 Form 483s on file for Viatris, Inc.; the most recent is dated Jun 26, 2024.
When was Viatris, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Viatris, Inc. is a Form 483 dated Jun 26, 2024, for the site in Pithampur, District Dhar, India.
What did FDA cite at Viatris, Inc.?
The regulations cited most in the observations on file for Viatris, Inc. are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.103 (Calculation of yield), 1 time; 21 CFR 211.192 (Production record review), 1 time.
Has Viatris, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Viatris, Inc.; the most recent is dated Dec 19, 2024.