Overview
- 7 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-18.
At a glance
Inspections
7
Form 483s
7
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 May 2026 – 18 May 2026 | Human Drugs | 483 | View 483 → |
| 7 Feb 2022 – 17 Feb 2022 | Human Drugs | 483 | View 483 → |
| 10 Jan 2018 – 26 Jan 2018 | Human Drugs | 483 | View 483 → |
| 12 Jul 2016 – 26 Jul 2016 | Human Drugs | 483 | View 483 → |
| 8 Jun 2015 – 19 Jun 2015 | Human Drugs | 483 | View 483 → |
| 5 Mar 2014 – 11 Mar 2014 | Human Drugs | 483 | View 483 → |
| 8 Jul 2013 – 16 Jul 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
18 May 2026
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Jose M Cayuela, Christian F Gomez Lugo
18 May 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Jose M Cayuela, Christian F Gomez Lugo
18 May 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jose M Cayuela, Christian F Gomez Lugo
18 May 2026
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Jose M Cayuela, Christian F Gomez Lugo
17 Feb 2022
21 CFR 211.165(a)
Testing and release for distribution
Cited by Miguel A Martinez, Marian E Ramirez, Marlene Rodriguez Colon
Investigators
FDA investigators tied to this site in the record.
Marian E Ramirez2 insp.
Jose F Velez2 insp.
Jose M Cayuela1 insp.
Christian F Gomez Lugo1 insp.
Miguel A Martinez1 insp.
Marlene Rodriguez Colon1 insp.
German Rivera1 insp.
Edwin Martinez1 insp.
Noreen Muniz1 insp.
Chelsea N Sealey1 insp.
Jose R Lopez1 insp.
Jose A Cruz Gonzalez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | 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