483
Genesis Biosystems, IncFDA 483 - Genesis Biosystems, Inc - January 09, 2023
Record Details
Genesis Biosystems, Inc., a medical device manufacturer in Lewisville, TX, received a Form FDA 483 with three observations during an inspection. The firm was cited for deficiencies in its complaint handling procedures, issues with internal audit independence, and inadequate supplier management records. Notably, one observation regarding supplier management was a repeat finding from a previous inspection.
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ID · 215725ca-d209-4219-aa72-efaba79b09b1