# FDA 483 - Merck Serono S.p.A. - May 10, 2023

Source: https://www.globalkeysolutions.net/records/483/merck-serono-spa/a8eb71fd-5dd2-498d-9056-6668c859061a

> FDA 483 for Merck Serono S.p.A. on May 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck Serono S.p.A.
- Inspection Date: 2023-05-10
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Merck Serono S.p.A. - (MS-Bari), a drug product manufacturer in Bari, Italy, revealed multiple deficiencies in their manufacturing operations. Observations included issues with aseptic processing design, inadequate control strategies for product and excipients, and unvalidated sterilization processes. Further concerns were raised regarding inadequate equipment maintenance and insufficient cleaning and disinfection practices in aseptic areas.

## Related Officers

- [Richard Ledwidge](https://www.globalkeysolutions.net/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)

Company: https://www.globalkeysolutions.net/companies/merck-serono-spa/052a4b09-0189-4f5c-bdcc-33182a7d3488

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