483
Quality Chemical LaboratoriesQuality Chemical Laboratories – FDA 483, Nov 20, 2024
Record Details
An FDA inspection of Quality Chemical Laboratories in Wilmington, NC, a contract testing laboratory and manufacturer, revealed two significant observations. The firm was cited for inadequate qualification of an oven used for depyrogenation and for failing to conduct comprehensive root cause analyses for failed endotoxin results. These issues indicate deficiencies in equipment validation and quality unit investigation practices.
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ID · d7ce1e9a-dc21-45cf-bd04-c6393b34f523
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