483
Geneva Laboratories, IncFDA 483 - Geneva Laboratories, Inc - June 01, 2021
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Genesis Laboratories, Inc, a contract laboratory in Elkhorn, WI, was inspected from June 1-3, 2021. The inspection revealed significant issues with test method validation and data integrity, specifically concerning computer system controls and protection of electronic records. These findings indicate serious deficiencies in quality control and data management practices.
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ID · eb077985-b4f5-4f30-bf0f-9d540d6e5359