# FDA 483 - Merck Biodevelopment - Unknown Date

Source: https://www.keypedia.com/records/483/merck-biodevelopment/95a0dafc-f45d-4c31-952d-38596d3cd78f

> FDA 483 for Merck Biodevelopment on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck Biodevelopment
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Merck BioDevelopment in Martillac, France, a drug substance manufacturing facility, was cited for significant quality system deficiencies. The inspection revealed inadequate investigations into deviations, particularly concerning visible particles in drug substance intermediates, and incomplete documentation for various deviations, including a lack of root cause analysis and preventive actions. Additionally, temporary equipment storage conditions were not properly assessed for microbial contamination risks, leading to bioburden excursions.

## Related Documents

- [483 - 2022-10-14](https://www.keypedia.com/records/483/merck-biodevelopment/4b27c7d5-a22d-46b2-9a5c-76ab2b1394ea)

## Related Officers

- [Chen Sun Ph.D., Biologist](https://www.keypedia.com/people/chen-sun-phd-biologist/23c466aa-654e-427d-bb43-3cef2a4b818c)
- [Richard Ledwidge, Ph.D., Biologist](https://www.keypedia.com/people/richard-ledwidge-phd-biologist/51161c1e-63da-4f24-bf8b-ecc1398c9dbe)
- [Matthew Casale, Investigator](https://www.keypedia.com/people/matthew-casale-investigator/6d265e1b-4375-4702-af40-8315ff4a267d)

Company: https://www.keypedia.com/companies/merck-biodevelopment/3db28a71-687c-4930-ade4-7ab5d59dce23

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd