Overview
- 23 FDA inspections are on record.
- 16 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-21.
At a glance
Inspections
23
Form 483s
16
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Nov 2025 – 21 Nov 2025 | Biologics | Clean | |
| 8 Jan 2025 – 22 Jan 2025 | Human Drugs | 483 | On file |
| 18 Apr 2023 – 26 Apr 2023 | Biologics | Clean | |
| 25 Feb 2020 – 4 Mar 2020 | Biologics | 483 | On file |
| 24 Jun 2019 – 28 Jun 2019 | Human Drugs | 483 | View 483 → |
| 18 Oct 2018 – 26 Oct 2018 | Biologics | 483 | On file |
| 8 Jan 2018 – 19 Jan 2018 | Human Drugs | Clean | |
| 17 Apr 2017 – 21 Apr 2017 | Human Drugs | Clean | |
| 8 Nov 2016 – 18 Nov 2016 | Biologics | 483 | On file |
| 24 Aug 2015 – 3 Sep 2015 | Human Drugs | Clean | |
| 17 Aug 2015 – 21 Aug 2015 | Human Drugs | 483 | On file |
| 3 Jun 2014 – 10 Jun 2014 | Biologics | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Aug 2012
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Nebil A Oumer, Brooke K Higgins
29 Sep 2009
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Brooke K Higgins, Ernest Bizjak
Investigators
FDA investigators tied to this site in the record.
Brooke K Higgins6 insp.
Rachel C Harrington4 insp.
Susan M Jackson3 insp.
Jonathan W Chapman3 insp.
Qin Xu3 insp.
Burnell M Henry2 insp.
Jessica L Pressley2 insp.
Ernest Bizjak2 insp.
Miriam M Ngundi1 insp.
Brandy N Lepage1 insp.
Karishma G Gopaul1 insp.
Thomas R Withers1 insp.
Thai D Truong1 insp.
Robin Levis1 insp.
Swati Verma1 insp.
David A Oluwo1 insp.
Justin A Boyd1 insp.
Marcus A Ray1 insp.
Ileana Barreto-Pettit1 insp.
Steven P Donald1 insp.
Mihaly S Ligmond1 insp.
Debra M Emerson1 insp.
Nebil A Oumer1 insp.
Anthony F Lorenzo1 insp.
Nawab A Siddiqui1 insp.
Jacqueline M Diaz Albert1 insp.
Christian Lynch1 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 | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Merck Sharp & Dohme LLC's 16 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