# FDA 483 - Merck Serono SA - July 08, 2022

Source: https://www.globalkeysolutions.net/records/483/merck-serono-sa/736f1912-9818-4689-b96f-1747753f5240

> FDA 483 for Merck Serono SA on July 08, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck Serono SA
- Inspection Date: 2022-07-08
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Merck Serono S.A. (MS-Aubonne) in Aubonne, Switzerland, was inspected by the FDA, revealing significant deficiencies in its sterile drug product manufacturing processes. The inspection highlighted inadequate procedures for preventing microbiological contamination, environmental monitoring, cleaning and disinfection, and critical utility qualification. Additionally, the firm's deviation investigations, electronic data system controls, and quality assurance oversight were found to be insufficient, indicating a broad range of issues impacting product sterility and quality.

## Related Officers

- [Zhong Li](https://www.globalkeysolutions.net/people/zhong-li/18545b20-7fa5-4850-9dd4-cffb40c41f8d)
- [Quality System Specialist](https://www.globalkeysolutions.net/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Richard Ledwidge](https://www.globalkeysolutions.net/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)

Company: https://www.globalkeysolutions.net/companies/merck-serono-sa/11522eec-8d30-492a-90ba-09b167899bdc

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