FDA Inspection
Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC – FDA Inspection, Aug 23, 2024
Record Details
This FDA Inspection record concerns Merck Sharp & Dohme LLC, with an inspection on August 23, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 5bded934-b3a4-469f-b2ba-f705b6b783e2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1229927
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
FDA Citations
2- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
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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 | |
| 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 |
| April 30, 2019 | VAI | Philadelphia District Office | Bioresearch Monitoring |
Other documents for Merck Sharp & Dohme LLC
- FDA Inspection 1275520 - 2025-07-15
- FDA Inspection 1252348 - 2024-12-12
- FDA Inspection 1155052 - 2021-07-27
- FDA Inspection 1103540 - 2019-09-20
- FDA Inspection 1087963 - 2019-04-30
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