# FDA 483 - Merck Sharp & Dohme LLC - April 16, 2021

Source: https://www.keypedia.com/records/483/merck-sharp-dohme-llc/8eeb13af-941d-45fe-be1d-581c3e337c75

> FDA 483 for Merck Sharp & Dohme LLC on April 16, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck Sharp & Dohme LLC
- Inspection Date: 2021-04-16
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: Merck Sharp & Dohme Corp. in Durham, NC, received a Form 483 with six observations during an FDA inspection from April 7-16, 2021. The observations highlight significant deficiencies in equipment maintenance, facility upkeep, quality control unit authority, batch record documentation, equipment routine checking, and written production procedures for vaccine manufacturing. These issues pose risks to the quality and purity of vaccine products like Varivax, Zostavax, and MMR II.

## Related Documents

- [EIR - 2021-04-16](https://www.keypedia.com/records/eir/merck-sharp-dohme-llc/92501760-1393-44ea-8dc5-32fa013e2df2)

## 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)
- [Gene T Alzy](https://www.keypedia.com/people/gene-t-alzy/1a792c81-a87e-46a0-9112-7d25fadf4e95)

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

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7