Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-25.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jul 2025 – 25 Jul 2025 | Human Drugs | 483 | View 483 → |
| 27 Feb 2019 – 6 Mar 2019 | Human Drugs | Clean | |
| 21 Apr 2016 – 26 Apr 2016 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jul 2025
21 CFR 211.180(e)(1)
Review of representative number of batches
Cited by Vivin George, Kara J Wright
25 Jul 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Vivin George, Kara J Wright
Investigators
FDA investigators tied to this site in the record.
Vivin George1 insp.
Kara J Wright1 insp.
Joanne E King1 insp.
Glenn S Quintanilla1 insp.
Richard A Lyght1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ProSolus Inc's 2 Form 483s
Source PDFs 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