Quality Chemical LaboratoriesNovember 20, 2024

FDA 483 - Quality Chemical Laboratories - November 20, 2024

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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.

Company: Quality Chemical Laboratories
Inspection Date: November 20, 2024
Product Type: Drugs
Office: Atlanta District Office
People: Oluwasefunmi Agbanigo
Saundrea A. Munroe (Drug Specialist / Drug Investigator)

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ID · d7ce1e9a-dc21-45cf-bd04-c6393b34f523