FDA Inspection
Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC – FDA Inspection, Apr 30, 2019
Record Details
This FDA Inspection record concerns Merck Sharp & Dohme LLC, with an inspection on April 30, 2019, issued by the Philadelphia District Office, covering human drugs.
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ID · 205cf7fa-631d-431d-8b6e-4ae49a333149
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087963
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 58.130(a)Conduct: in accordance with protocol
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Other FDA inspections of Merck Sharp & Dohme LLC
15| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2025 | Not classified | Philadelphia District Office | |
| December 12, 2024 | Not classified | Philadelphia District Office | |
| August 23, 2024 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| July 27, 2021 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| September 20, 2019 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
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 1103540 - 2019-09-20
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