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BDJ Open 9 , 49 (2023)

Much of the evidence remains anecdotal or derived from animal studies, emphasizing the importance of caution and professional guidance

Decades of subsequent research have broadened the picture

"Your firm did not implement effective CAPA to reduce recurrence of severe contamination hazards including, but not limited to, operator error that had contributed significantly to recurring sterility and media-fill failures over the past five years," the agency added