Overview
- 31 FDA inspections are on record.
- 18 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-15.
At a glance
Inspections
31
Form 483s
18
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jul 2025 – 15 Jul 2025 | Human Drugs | Clean | |
| 5 Dec 2024 – 12 Dec 2024 | Human Drugs | Clean | |
| 13 Aug 2024 – 23 Aug 2024 | Biologics | 483 | View 483 → |
| 11 Apr 2022 – 19 Apr 2022 | Biologics | Clean | |
| 15 Jul 2021 – 27 Jul 2021 | Biologics | 483 | On file |
| 9 Sep 2019 – 20 Sep 2019 | Biologics | 483 | On file |
| 22 Apr 2019 – 30 Apr 2019 | Human Drugs | 483 | View 483 → |
| 18 Apr 2017 – 28 Apr 2017 | Human Drugs | 483 | On file |
| 22 Jun 2015 – 26 Jun 2015 | Biologics | 483 | On file |
| 12 Mar 2015 – 17 Apr 2015 | Biologics | 483 | On file |
| 2 Sep 2014 – 12 Sep 2014 | Human Drugs | 483 | View 483 → |
| 20 Sep 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Aug 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Travis S Bradley, Unnee Ranjan, Olga Simakova
23 Aug 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Travis S Bradley, Unnee Ranjan, Olga Simakova
30 Apr 2019
21 CFR 58.130(a)
Conduct: in accordance with protocol
Cited by Anastasia I Offordile, Kelly N Kerr, Anastasia I Onuorah
30 Apr 2019
21 CFR 58.130(a)
Conduct: in accordance with protocol
Cited by Anastasia I Offordile, Kelly N Kerr, Anastasia I Onuorah
12 Sep 2014
21 CFR 211.160(b)(1)
Incoming lots - conformance to written specs-
Cited by Anita R Michael, Junho Pak
Investigators
FDA investigators tied to this site in the record.
Anastasia I Onuorah2 insp.
Linda Thai2 insp.
Omotunde O Osunsanmi2 insp.
Julianne C Mccullough2 insp.
Jacqueline M Diaz Albert2 insp.
Christina K Theodorou1 insp.
Nelson N Ayangho1 insp.
Travis S Bradley1 insp.
Unnee Ranjan1 insp.
Olga Simakova1 insp.
Stephanie C Mangigian1 insp.
Gene D Arcy1 insp.
Brentley S Collins1 insp.
Christopher J Adams1 insp.
Eileen A Liu1 insp.
Prabhu P Raju1 insp.
Anissa M Cheung1 insp.
Scott E Norris1 insp.
Anastasia I Offordile1 insp.
Kelly N Kerr1 insp.
Mihaly S Ligmond1 insp.
Craig D Zagata1 insp.
Marian Major1 insp.
Jeremy L Wally1 insp.
Ellen Huang1 insp.
Simone E Pitts1 insp.
Cynthia Jim1 insp.
Anita R Michael1 insp.
Junho Pak1 insp.
James M Mason1 insp.
Brian S Keefer1 insp.
Ramon E Martinez1 insp.
Helen B Ricalde1 insp.
Hala L Selby1 insp.
Christian Lynch1 insp.
Paula A Trost1 insp.
Rose M Ashley1 insp.
Rebecca K Olin1 insp.
Joseph George1 insp.
Margaret E Digennaro1 insp.
Vlada Matusovsky1 insp.
Joanne M Hajoway1 insp.
Karyn M Campbell1 insp.
Joan A Loreng1 insp.
Ann M Montemurro1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.130(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Merck Sharp & Dohme LLC's 18 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