483
Bachem Americas, Inc.Bachem Americas, Inc. – FDA 483, Feb 10, 2017
Record Details
An FDA inspection of Bachem Americas, Inc. in Vista, CA, revealed two significant observations. The firm failed to implement appropriate controls over computer systems, specifically a titrator used for API moisture content, lacking validation and unauthorized data control. Additionally, a leaking plumbing system was observed near the manufacturing area, posing a contamination risk to drug products.
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ID · 7ccbb52d-8066-427b-b84f-7cfe2e5b0e78
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