483
Novartis Pharma Stein AGFDA 483 - Novartis Pharma Stein AG - September 21, 2018
Record Details
An FDA inspection of Novartis Pharma Stein A.G., a sterile drug manufacturer in Stein, Switzerland, revealed significant issues across three observations. These included inadequate maintenance of a critical manufacturing system, lack of cleaning validation for a fill line, and failure to follow written procedures during manufacturing, specifically regarding material booking and inventory management.
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ID · 7b770256-872c-467d-b840-a8336bd5c659
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