Overview
- 10 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-13.
At a glance
Inspections
10
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Feb 2026 – 13 Feb 2026 | Biologics | 483 | On file |
| 8 Sep 2025 – 12 Sep 2025 | Human Drugs | 483 | View 483 → |
| 13 Nov 2023 – 16 Nov 2023 | Biologics | Clean | |
| 1 Apr 2019 – 5 Apr 2019 | Medical Devices & Rad Health | Clean | |
| 1 May 2018 – 3 May 2018 | Human Drugs | Clean | |
| 19 Jan 2016 – 21 Jan 2016 | Human Drugs | Clean | |
| 25 Jun 2013 – 28 Jun 2013 | Human Drugs | Clean | |
| 11 Dec 2009 | Not recorded | Clean | |
| 15 Jul 2004 | Not recorded | Clean | |
| 14 Jan 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Sep 2025
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Santos E Camara, Megan T Ziegler, Mabany Lizardi
12 Sep 2025
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Santos E Camara, Megan T Ziegler, Mabany Lizardi
12 Sep 2025
21 CFR 211.182
Written records kept in individual logs
Cited by Santos E Camara, Megan T Ziegler, Mabany Lizardi
12 Sep 2025
21 CFR 211.192
No written record of investigation
Cited by Santos E Camara, Megan T Ziegler, Mabany Lizardi
12 Sep 2025
21 CFR 211.63
Equipment Design, Size and Location
Cited by Santos E Camara, Megan T Ziegler, Mabany Lizardi
Investigators
FDA investigators tied to this site in the record.
Sonya M Edmonds2 insp.
Seneca D Toms2 insp.
Grace I Cortesini1 insp.
Ivey M Choi1 insp.
Santos E Camara1 insp.
Megan T Ziegler1 insp.
Mabany Lizardi1 insp.
Brentley S Collins1 insp.
Travis S Bradley1 insp.
Brentley S Pittman1 insp.
Nydia E Colon1 insp.
Adam R Cooke1 insp.
Jason F Chancey1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Merck Sharp & Dohme LLC'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