Overview
- 9 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-20.
At a glance
Inspections
9
Form 483s
7
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 May 2026 – 20 May 2026 | Biologics | 483 | On file |
| 4 Jun 2024 – 12 Jun 2024 | Biologics | Clean | |
| 7 Apr 2021 – 16 Apr 2021 | Biologics | 483 | View 483 → |
| 22 Oct 2018 – 30 Oct 2018 | Biologics | 483 | View 483 → |
| 14 Nov 2016 – 21 Nov 2016 | Biologics | 483 | On file |
| 17 Nov 2014 – 24 Nov 2014 | Biologics | 483 | On file |
| 13 Jan 2014 – 17 Jan 2014 | Biologics | 483 | On file |
| 31 Aug 2012 | Not recorded | Clean | |
| 14 May 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Apr 2021
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Gene D Arcy, Scott T Ballard, Laurel A Beer
16 Apr 2021
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Gene D Arcy, Scott T Ballard, Laurel A Beer
16 Apr 2021
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Gene D Arcy, Scott T Ballard, Laurel A Beer
16 Apr 2021
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Gene D Arcy, Scott T Ballard, Laurel A Beer
16 Apr 2021
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Gene D Arcy, Scott T Ballard, Laurel A Beer
Investigators
FDA investigators tied to this site in the record.
Burnell M Henry2 insp.
Laurel A Beer2 insp.
Gene D Arcy2 insp.
Susan M Jackson2 insp.
Robert D Tollefsen2 insp.
Destry M Sillivan2 insp.
Lizaida Perez1 insp.
Scott T Ballard1 insp.
Arie Menachem1 insp.
Prabhu P Raju1 insp.
Seneca D Toms1 insp.
Chad R Burger1 insp.
Jeremy L Wally1 insp.
Randa Melhem1 insp.
Joseph D Doleski1 insp.
Nawab A Siddiqui1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.14(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Merck Sharp & Dohme LLC's 7 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