483
I 3 PHARMACEUTICALS, LLCI 3 PHARMACEUTICALS, LLC – FDA 483, Mar 3, 2023
Record Details
I3 Pharmaceuticals LLC, a drug manufacturer in Warminster, PA, received two observations during an FDA inspection. The firm was cited for deficiencies in equipment qualification, specifically regarding drying times and inlet airflow ranges for manufacturing processes. Additionally, the inspection found inadequate written procedures for equipment cleaning and maintenance, including issues with the dirty hold time study.
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