FDA Inspection
Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC – FDA Inspection, Jun 28, 2019
Record Details
This FDA Inspection record concerns Merck Sharp & Dohme LLC, with an inspection on June 28, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 1244c1cd-856f-4688-8886-97fccee4b2a5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1094564
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.42(d)Penicillin processing area not kept separate
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Merck Sharp & Dohme LLC
18| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2025 | Not classified | Baltimore District Office | |
| January 22, 2025 | Not classified | Baltimore District Office | |
| April 26, 2023 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| March 4, 2020 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| October 26, 2018 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
Other documents for Merck Sharp & Dohme LLC
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- FDA Inspection 1210555 - 2023-04-26
- FDA Inspection 1123248 - 2020-03-04
- FDA Inspection 1073392 - 2018-10-26
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