# FDA 483 - Merck Serono SA (Vevey) - April 06, 2023

Source: https://www.keypedia.com/records/483/merck-serono-sa-vevey/c34c627c-a097-4956-b8f6-66f8d567d2fe

> FDA 483 for Merck Serono SA (Vevey) on April 06, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck Serono SA (Vevey)
- Inspection Date: 2023-04-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Merck Serono SA (Vevey), a drug substance manufacturer in Corsier-Sur-Vevey, Switzerland, was cited for failing to adequately monitor its water purification system. The inspection revealed undocumented water leaks from multiple tanks, which were not properly addressed or documented upon discovery, potentially impacting the quality of water used in drug manufacturing.

## Related Officers

- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)
- [Vaishali J. Patel](https://www.keypedia.com/people/vaishali-j-patel/3d515b84-e0fd-4f96-914c-f7f09e2de307)

Company: https://www.keypedia.com/companies/merck-serono-sa-vevey/e86df39a-6cb6-4ab2-a811-47c8369ba270

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1