# FDA EIR - Merck Sharp & Dohme LLC - April 16, 2021

Source: https://www.keypedia.com/records/eir/merck-sharp-dohme-llc/92501760-1393-44ea-8dc5-32fa013e2df2

> FDA EIR for Merck Sharp & Dohme LLC on April 16, 2021. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Merck Sharp & Dohme LLC
- Inspection Date: 2021-04-16
- Product Type: Biologics
- Office Name: Team Biologics
- Summary: An FDA Level 1 Good Manufacturing Practice (GMP) inspection of Merck Sharp & Dohme Corp.'s Durham, NC facility was conducted from April 7 to April 16, 2021. The inspection, guided by Compliance Program 7345.848, focused on the manufacturing of licensed biological drug products, including vaccines like M-M-R II and VARIVAX. The inspection covered quality, production, facilities and equipment, and laboratory systems. During this inspection, a FORM FDA-483 was issued, documenting several objectionable conditions. These included a failure to adequately manage and store drug product closures to prevent contamination; insufficient maintenance of manufacturing buildings; a quality control unit lacking full authority to investigate errors; incomplete batch production and control records; inadequate routine equipment performance checks; and the absence of written procedures to ensure drug product identity, strength, quality, and purity. Importantly, the inspection also verified that all objectionable conditions noted in the previous 2018 inspection had been corrected. In response to the current findings, company management committed to submitting a written response to the U.S. FDA, outlining their proposed corrective actions to address the identified issues.

## Related Documents

- [483 - 2021-04-16](https://www.keypedia.com/records/483/merck-sharp-dohme-llc/8eeb13af-941d-45fe-be1d-581c3e337c75)

## Related Officers

- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [Laurel A. Beer](https://www.keypedia.com/people/laurel-a-beer/0ac1e74f-0ff6-4db6-a0e8-0c3fb013720e)
- [company_representative](https://www.keypedia.com/people/jesse-byrne/4c42b2d8-2494-494f-8be2-820d065cdb3e)
- [company_representative](https://www.keypedia.com/people/jeffrey-najarian/5262a51e-3f02-422f-9de5-469429b7d640)
- [company_representative](https://www.keypedia.com/people/amy-dimmette/66e9876a-d3de-4155-91ab-8d96beb020f4)

Company: https://www.keypedia.com/companies/merck-sharp-dohme-llc/967df80c-3ba2-42c7-918c-af2c89dc721c

Office: https://www.keypedia.com/offices/team-biologics/05484e1e-6fab-47a3-b680-ec2a393a202f