Merck Serono SA (Vevey)April 6, 2023

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

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Record Details

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.

Company: Merck Serono SA (Vevey)
Inspection Date: April 6, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Santos E. Camara
Vaishali J. Patel

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ID · c34c627c-a097-4956-b8f6-66f8d567d2fe