Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-05-19.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 May 2026 – 19 May 2026 | Human Drugs | Clean | |
| 6 Nov 2023 – 8 Nov 2023 | Human Drugs | 483 | View 483 → |
| 12 Dec 2022 – 19 Dec 2022 | Human Drugs | Clean | |
| 27 Feb 2019 – 15 Mar 2019 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Nov 2023
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Michael Serrano, Mayar M Mussa
Investigators
FDA investigators tied to this site in the record.
Jay B Shah1 insp.
Michael Serrano1 insp.
Mayar M Mussa1 insp.
Janet A Rajan1 insp.
Yvesna C Blaise1 insp.
Monika Borkowska1 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 314.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Quagen Pharmaceuticals LLC's 1 Form 483
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