Company
United StatesMerck Teknika LLC, Durham, NC – FDA Inspections
Inspection records and compliance data for Merck Teknika LLC in Durham, North Carolina. 6 FDA inspections on record, 2 Form 483s, last inspected November 27, 2024.
Company Profile
This profile covers Merck Teknika LLC based in Durham, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 5
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected May 25, 2011. Last inspected November 27, 2024.
Most cited issue areas
- Cleaning / Sanitizing / Maintenance1 inspection
- Equipment Design, Size and Location1 inspection
- Investigations of discrepancies, failures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 27, 2024 | VAI | Biologics · Vaccine, Allergenic, and Live Biotherapeutic Products | 1256979 |
| February 23, 2022 | NAI | Biologics · Vaccines and Allergenic Products | 1165270 |
| January 24, 2020 | VAI | Biologics · Vaccines and Allergenic Products | 1115970 |
| March 22, 2018 | VAI | Biologics · Vaccines and Allergenic Products | 1051124 |
| March 25, 2013 | VAI | Biologics · Vaccines and Allergenic Products | 825705 |
| May 25, 2011 | VAI | Biologics · Vaccines and Allergenic Products | 728630 |
FDA documents
EIRs (1)
People (6)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Merck Teknika LLC
FEI Number
1039284
Address
100 Rodolphe St Bldg 1300, Durham, North Carolina 27712, United States
Country
United States
ID: 64024257-325c-45de-a5c2-70cbe8abecf5