483
Merck Serono SA (Vevey)FDA 483 - Merck Serono SA (Vevey) - April 06, 2023
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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.
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ID · c34c627c-a097-4956-b8f6-66f8d567d2fe