# Merck & Co. Inc – FDA 483, Aug 26, 2016

Source: https://www.keypedia.com/records/483/merck-co-inc/c734e6e3-310b-4d49-a3c1-36825b6ea22b

> FDA 483 for Merck & Co. Inc on August 26, 2016. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Merck & Co. Inc
- Inspection Date: 2016-08-26
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Merck Sharp & Dohme received a Form FDA 483 for significant deficiencies in clinical study oversight and investigator management. The firm failed to ensure proper monitoring, including verifying source documents and overseeing subcontracted organizations. Additionally, Merck did not promptly address or terminate non-compliant investigators and failed to notify the FDA of such terminations.

## Related Documents

- [EIR - 2019-09-06](https://www.keypedia.com/records/eir/merck-co-inc/c7e8cc93-30f7-4f77-8b72-51df9de21d0b) — date: September 6, 2019
- [483 - 2015-11-19](https://www.keypedia.com/records/483/merck-co-inc/0aff043d-e9b8-420c-b9e3-04ea44273bb9) — date: November 19, 2015

## Related Officers

- [investigator](https://www.keypedia.com/people/nina-yang/8d080437-2e05-4b75-8c53-b818d761cf1f)
- [Shirley S. Wen](https://www.keypedia.com/people/shirley-s-wen/eafbc8e5-a0ac-443a-adaf-ced505f77842)
- [Sean W Mulcinde](https://www.keypedia.com/people/sean-w-mulcinde/5f933df1-8f2e-4dea-9aca-e136329f77c2)
- [investigator](https://www.keypedia.com/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)

Company: https://www.keypedia.com/companies/merck-co-inc/a46a094a-b27d-49bf-bde5-42441f92c622

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