FDA Inspection
Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC – FDA Inspection, Sep 12, 2014
Record Details
This FDA Inspection record concerns Merck Sharp & Dohme LLC, with an inspection on September 12, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Merck Sharp & Dohme LLC
- Inspection Date
- September 12, 2014
- Product Type
- Drugs
View Company Profile
ID · f1ab59e5-0c5f-4f9d-bc4c-23f8fb528b42
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 895238
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
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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 |
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- FDA Inspection 1229927 - 2024-08-23
- FDA Inspection 1155052 - 2021-07-27
- FDA Inspection 1103540 - 2019-09-20
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