I3 PHARMACEUTICALS LLCMarch 3, 2023

FDA 483 - I3 PHARMACEUTICALS LLC - March 03, 2023

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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.

Company: I3 PHARMACEUTICALS LLC
Inspection Date: March 3, 2023
Product Type: Drugs
Office: Philadelphia District Office
People: Amit Kokate
Janet A. Rajan (Investigator)
Daniel J. Min (Consumer Safety Officer)

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