FDA Inspection
Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC – FDA Inspection, Oct 30, 2018
Record Details
This FDA Inspection record concerns Merck Sharp & Dohme LLC, with an inspection on October 30, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Person
- Arie Menachem (Issuing Officer)
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ID · c4ddaf31-147b-4079-bd9f-3f595b9b7887
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1070336
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 600.14(a)(1)Who must report - manufacturer
- 21 CFR 211.198(a)Procedures to be written and followed
- 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
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 20, 2026 | Not classified | Atlanta District Office | |
| June 12, 2024 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| April 16, 2021 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| November 21, 2016 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| November 24, 2014 | VAI | Center for Biologics Evaluation and Research | Vaccines 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 998099 - 2016-11-21
- FDA Inspection 903682 - 2014-11-24
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