Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-17.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Apr 2026 – 17 Apr 2026 | Human Drugs | Clean | |
| 4 May 2023 – 9 May 2023 | Human Drugs | Clean | |
| 13 Oct 2020 – 26 Oct 2020 | Human Drugs | 483 | View 483 → |
| 4 Nov 2019 – 8 Nov 2019 | Human Drugs | 483 | View 483 → |
| 26 Feb 2019 – 15 Mar 2019 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Monika Borkowska2 insp.
Emmanuel T Donyina1 insp.
Anthony J Donato1 insp.
Josh Renzo N Ramilo1 insp.
Niketa Patel1 insp.
Zhe J Tang1 insp.
Yvesna C Blaise1 insp.
Mesfin Abdi1 insp.
Amit Kokate1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | 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(b)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Quagen Pharmaceuticals LLC's 3 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