# FDA 483 - Merck Sharp & Dohme LLC - November 19, 2015

Source: https://www.globalkeysolutions.net/records/483/merck-sharp-dohme-llc/0aff043d-e9b8-420c-b9e3-04ea44273bb9

> FDA 483 for Merck Sharp & Dohme LLC on November 19, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck Sharp & Dohme LLC
- Inspection Date: 2015-11-19
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Merck Sharp & Dohme in Rahway, NJ, was cited for significant deficiencies in its conduct and oversight of clinical investigations, specifically Protocol No. P04103. The inspection revealed failures in reporting critical safety and effectiveness data, ensuring adherence to investigational plans, and proper study monitoring. These issues indicate a lack of robust controls over clinical trial data integrity and regulatory reporting.

## Related Documents

- [483 - 2016-08-26](https://www.globalkeysolutions.net/records/483/merck-sharp-dohme-llc/c734e6e3-310b-4d49-a3c1-36825b6ea22b)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/christina-burkhart/ab17df57-2a72-4262-920c-c63cb8f52114)
- [Cynthia Kleppinger](https://www.globalkeysolutions.net/people/cynthia-kleppinger/8badb3bc-141f-4094-a02b-b572fdb68fbf)
- [investigator](https://www.globalkeysolutions.net/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)

Company: https://www.globalkeysolutions.net/companies/merck-sharp-dohme-llc/a46a094a-b27d-49bf-bde5-42441f92c622

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248