# FDA 483 - Merck Sharp & Dohme LLC - Unknown Date

Source: https://www.keypedia.com/records/483/merck-sharp-dohme-llc/a37a43f6-5ab5-4504-8891-7a0a2aba2aa9

> FDA 483 for Merck Sharp & Dohme LLC on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck Sharp & Dohme LLC
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Merck Sharp & Dohme Corp., a sterile drug substance manufacturer in Elkton, VA, received a Form 483 with four observations during an inspection from February 25 to March 4, 2020. The observations primarily concern ineffective corrective actions for foreign material, inadequate Quality Assurance oversight of batch data, failure to properly investigate and follow up on out-of-specification results for HPV positive controls, and deficiencies in laboratory controls for HPV vaccine testing. These issues indicate significant concerns with quality systems and control over manufacturing and testing processes.

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## Related Officers

- [investigator](https://www.keypedia.com/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)
- [Investigator](https://www.keypedia.com/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

Company: https://www.keypedia.com/companies/merck-sharp-dohme-llc/a9539664-d21e-42b0-9b17-b399cf4873ef

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