# FDA 483 - Merck Sharp & Dohme LLC - April 30, 2019

Source: https://www.keypedia.com/records/483/merck-sharp-dohme-llc/d805733b-38ac-429b-acd8-52ebec9a0770

> FDA 483 for Merck Sharp & Dohme LLC on April 30, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck Sharp & Dohme LLC
- Inspection Date: 2019-04-30
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Merck Sharp & Dohme Corp.'s nonclinical laboratory in West Point, PA, revealed that not all nonclinical laboratory studies were conducted in accordance with their established protocols. Specifically, a study involving toxicokinetic blood collection was found to have instances where animals were dosed prior to sample collection, contrary to the protocol's requirements. This indicates a deviation from study procedures.

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## Related Officers

- [issuing_officer](https://www.keypedia.com/people/anastasia-offordile/299aed81-16f8-413e-a318-2d7f741957da)
- [investigator](https://www.keypedia.com/people/kelly-n-kerr/6f9e1ba0-61ca-403d-a337-9efece792c21)

Company: https://www.keypedia.com/companies/merck-sharp-dohme-llc/842c6e25-ee89-453c-a5b0-6b039c187744

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8