Overview
- 20 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-13.
At a glance
Inspections
20
Form 483s
6
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Mar 2026 – 13 Mar 2026 | Human Drugs | Clean | |
| 8 Dec 2025 – 18 Dec 2025 | Biologics | Clean | |
| 6 May 2025 – 16 May 2025 | Human Drugs | Clean | |
| 13 Mar 2025 – 27 Mar 2025 | Human Drugs | Clean | |
| 15 Nov 2021 – 18 Nov 2021 | Human Drugs | Clean | |
| 15 Nov 2021 – 18 Nov 2021 | Human Drugs | Clean | |
| 15 Nov 2021 – 18 Nov 2021 | Human Drugs | Clean | |
| 13 Oct 2021 – 27 Oct 2021 | Human Drugs | Clean | |
| 26 Aug 2019 – 6 Sep 2019 | Human Drugs | 483 | View 483 → |
| 16 Oct 2017 – 30 Oct 2017 | Human Drugs | 483 | View 483 → |
| 28 Nov 2016 – 6 Dec 2016 | Human Drugs | Clean | |
| 8 Aug 2016 – 26 Aug 2016 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Sep 2019
21 CFR 312.56(b)
Notification of FDA of termination of investigator
Cited by Peter R Lenahan
30 Oct 2017
21 CFR 312.50
General responsibilities of sponsors
Cited by Nina Yang, Michael Serrano, Shirley S Wen, Bei Yu
26 Aug 2016
21 CFR 312.50
General responsibilities of sponsors
Cited by Nina Yang, Michael Serrano, Shirley S Wen, Jean M Mulinde
26 Aug 2016
21 CFR 312.56(b)
Investigator non-compliance
Cited by Nina Yang, Michael Serrano, Shirley S Wen, Jean M Mulinde
26 Aug 2016
21 CFR 312.56(b)
Notification of FDA of termination of investigator
Cited by Nina Yang, Michael Serrano, Shirley S Wen, Jean M Mulinde
Investigators
FDA investigators tied to this site in the record.
Michael Serrano5 insp.
Guerlain Ulysse3 insp.
Anthony J Donato3 insp.
Annet R Rajan3 insp.
Mayar M Mussa2 insp.
Peter R Lenahan2 insp.
Nina Yang2 insp.
Shirley S Wen2 insp.
Agata E Libera1 insp.
Jay B Shah1 insp.
Gabrielle J Swain1 insp.
Kerun Hardeo1 insp.
Byungja E Marciante1 insp.
Bei Yu1 insp.
Jean M Mulinde1 insp.
Jonee J Mearns1 insp.
Frederick Razzaghi1 insp.
Addam S Reynolds1 insp.
Kristy A Zielny1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.50 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 312.56(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 312.57(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 312.58(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Merck & Co. Inc's 6 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