483
Frontida BioPharm IncFrontida BioPharm Inc – FDA 483, Dec 7, 2023
Record Details
An FDA inspection of Frontida BioPharm Inc. in Philadelphia, PA, revealed two significant observations. The firm failed to submit Field Alert Reports within the required timeframe for distributed drug products affected by out-of-specification raw material. Additionally, the inspection found deficiencies in the cleaning validation studies for manufacturing equipment, specifically regarding multi-batch campaigns.
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ID · c91263e1-f4e2-4769-aada-9f498f973d1f
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