483
Quagen Pharma, LLCFDA 483 - Quagen Pharma, LLC - March 15, 2019
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Record Details
Quagen Pharma, LLC, a drug manufacturer in West Caldwell, NJ, was cited for failing to follow written procedures for the cleaning and maintenance of equipment. Inspectors observed extensive product residue on a tube filling machine that was labeled as "cleaned," indicating a significant deviation from established protocols and potential impact on drug product quality.
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ID · bdb7744a-7068-46c2-9d56-752a455d041b