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FDA Inspection
•Merck Sharp & Dohme LLC•September 20, 2019

Merck Sharp & Dohme LLC – FDA Inspection, Sep 20, 2019

Record Details

This FDA Inspection record concerns Merck Sharp & Dohme LLC, with an inspection on September 20, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Merck Sharp & Dohme LLC
Inspection Date
September 20, 2019
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
People
  • Anissa M. Cheung (Issuing Officer)
  • Christopher J. Adams (Issuing Officer)
  • Eileen A. Liu
  • Linda Thai (FDA Associated Person)
  • Prabhu P. Raju (FDA Associated Person)
  • Scott E. Norris (Company Rep)
View Company Profile

ID · dcc1e4ee-5c35-4ce8-85b9-3a8b8e425941

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1103540
FDA center
Biologics
Project area
Vaccines and Allergenic Products
Outcome
Form 483 issued

Other FDA inspections of Merck Sharp & Dohme LLC

15
DateClassificationOfficeProject area
July 15, 2025Not classifiedPhiladelphia District Office
December 12, 2024Not classifiedPhiladelphia District Office
August 23, 2024VAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
July 27, 2021VAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
April 30, 2019VAIPhiladelphia District OfficeBioresearch Monitoring
View all 15 other inspections on the company page
Other documents for Merck Sharp & Dohme LLC
  • FDA Inspection 1275520 - 2025-07-15
  • FDA Inspection 1252348 - 2024-12-12
  • FDA Inspection 1229927 - 2024-08-23
  • FDA Inspection 1155052 - 2021-07-27
  • FDA Inspection 1087963 - 2019-04-30

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