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

Source: https://www.keypedia.com/records/483/merck-sharp-dohme-llc/0f66a4fc-0947-4026-9ece-e2ba69104767

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

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## Details

- Record Type: 483
- Company Name: Merck Sharp & Dohme LLC
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: Merck Sharp & Dohme Corporation in West Point, PA, was inspected regarding its biologics and vaccine operations. The inspection revealed significant issues including inadequate environmental controls in a vaccine production area, poor facility maintenance with a leaking roof affecting GMP spaces, and failures in complaint handling and medical device reporting for broken prefilled vaccine syringes. These observations indicate potential risks to product quality and patient safety.

## Related Documents

- [483 - 2019-04-30](https://www.keypedia.com/records/483/merck-sharp-dohme-llc/d805733b-38ac-429b-acd8-52ebec9a0770)
- [483 - 2019-09-09](https://www.keypedia.com/records/483/merck-sharp-dohme-llc/4991dc98-f2fb-404a-997c-26727b72fb45)
- [483 - 2024-08-23](https://www.keypedia.com/records/483/merck-sharp-dohme-llc/1dea200c-704e-401b-9776-f1543cb04387)
- [483 - Unknown Date](https://www.keypedia.com/records/483/merck-sharp-dohme-llc/23fe963f-f437-4f25-981f-ad46c475a27c)

## Related Officers

- [Gene D. Arcy](https://www.keypedia.com/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)
- [investigator](https://www.keypedia.com/people/brantley-s-collins/c806aac1-3d89-4427-8aeb-6d9db6dfc2f4)
- [Team Biologics Staff](https://www.keypedia.com/people/linda-thai/f4d9a1c3-e5e8-4f13-8abe-e1f1e597c8f8)

Company: https://www.keypedia.com/companies/merck-sharp-dohme-llc/842c6e25-ee89-453c-a5b0-6b039c187744

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8