483
Quagen Pharma, LLCQuagen Pharma, LLC – FDA 483, Oct 26, 2020
Record Details
An FDA inspection of Quagen Pharma, LLC, a drug manufacturer in West Caldwell, NJ, identified two significant observations. These observations highlight failures in personnel gowning practices, leading to potential drug product contamination, and a lack of adherence to written procedures for preparing sanitizing solutions used in equipment maintenance.
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ID · 55d3e58f-df6e-4ed1-b054-d5a36a188d34
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