Company
United StatesMerck Sharp & Dohme LLC, Durham, NC – FDA Inspections
Inspection records and compliance data for Merck Sharp & Dohme LLC in Durham, North Carolina. 6 FDA inspections on record, 3 Form 483s, last inspected May 20, 2026.
Company Profile
This profile covers Merck Sharp & Dohme LLC based in Durham, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected November 24, 2014. Last inspected May 20, 2026.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Authority lacking to review records, investigate errors1 inspection
- Buildings not maintained in good state of repair1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 20, 2026 | Not classified | Biologics | 1318208 |
| June 12, 2024 | NAI | Biologics · Vaccines and Allergenic Products | 1230849 |
| April 16, 2021 | VAI | Biologics · Vaccines and Allergenic Products | 1140222 |
| October 30, 2018 | VAI | Biologics · Vaccines and Allergenic Products | 1070336 |
| November 21, 2016 | VAI | Biologics · Vaccines and Allergenic Products | 998099 |
| November 24, 2014 | VAI | Biologics · Vaccines and Allergenic Products | 903682 |
FDA documents
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Company Information
Name
Merck Sharp & Dohme LLC
FEI Number
3006525584
Address
5325 Old Oxford Rd, Durham, North Carolina 27712, United States
Country
United States
ID: 967df80c-3ba2-42c7-918c-af2c89dc721c