Overview
- 14 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-13.
At a glance
Inspections
14
Form 483s
7
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Jun 2025 – 13 Jun 2025 | Human Drugs | Clean | |
| 10 Dec 2019 – 20 Dec 2019 | Human Drugs | 483 | On file |
| 19 Mar 2018 – 28 Mar 2018 | Human Drugs | 483 | View 483 → |
| 30 Nov 2016 – 8 Dec 2016 | Human Drugs | Clean | |
| 15 Sep 2015 – 25 Sep 2015 | Human Drugs | 483 | On file |
| 22 Jun 2015 – 2 Jul 2015 | Human Drugs | 483 | View 483 → |
| 5 Aug 2013 – 20 Aug 2013 | Human Drugs | 483 | View 483 → |
| 23 Sep 2011 | Not recorded | 483 | View 483 → |
| 8 Feb 2010 | Not recorded | 483 | View 483 → |
| 28 Nov 2007 | Not recorded | Clean | |
| 13 Dec 2005 | Not recorded | Clean | |
| 2 Jul 2004 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Mar 2018
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Raquel Gonzalez Rivera, Jose F Velez
28 Mar 2018
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Raquel Gonzalez Rivera, Jose F Velez
28 Mar 2018
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Raquel Gonzalez Rivera, Jose F Velez
28 Mar 2018
21 CFR 211.80(b)
Handling and Storage to Prevent Contamination
Cited by Raquel Gonzalez Rivera, Jose F Velez
Investigators
FDA investigators tied to this site in the record.
Jose A Cruz Gonzalez3 insp.
Noreen Muniz2 insp.
Raquel Gonzalez Rivera2 insp.
Angelica M Hernandez1 insp.
Yoriann M Cabrera Bartolomei1 insp.
Jose F Velez1 insp.
German Rivera1 insp.
Jose E Melendez1 insp.
Samina S Khan1 insp.
Moraima J Ramos-Valle1 insp.
Edwin Ortega1 insp.
Sixto M Mercado Rios1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Viatris Pharmaceuticals LLC's 7 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat