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FDA Inspection
•Merck Sharp & Dohme LLC•November 21, 2016

Merck Sharp & Dohme LLC – FDA Inspection, Nov 21, 2016

Record Details

This FDA Inspection record concerns Merck Sharp & Dohme LLC, with an inspection on November 21, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Merck Sharp & Dohme LLC
Inspection Date
November 21, 2016
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
People
  • Gene D. Arcy
  • Susan M. Jackson (Issuing Officer)
View Company Profile

ID · ee943d3f-a354-4a97-8609-5717fd6b933b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
998099
FDA center
Biologics
Project area
Vaccines and Allergenic Products
Outcome
Form 483 issued

Other FDA inspections of Merck Sharp & Dohme LLC

5
DateClassificationOfficeProject area
May 20, 2026Not classifiedAtlanta District Office
June 12, 2024NAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
April 16, 2021VAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
October 30, 2018VAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
November 24, 2014VAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
Other documents for Merck Sharp & Dohme LLC
  • FDA Inspection 1318208 - 2026-05-20
  • FDA Inspection 1230849 - 2024-06-12
  • FDA Inspection 1140222 - 2021-04-16
  • FDA Inspection 1070336 - 2018-10-30
  • FDA Inspection 903682 - 2014-11-24

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