HP Halden Pharma ASMay 10, 2023

FDA 483 - HP Halden Pharma AS - May 10, 2023

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Record Details

An FDA inspection of Fresenius Kabi Norge As, a drug manufacturer, revealed significant quality system deficiencies. The firm failed to thoroughly investigate discrepancies, maintain adequate production and process controls, and prevent contamination during material handling and storage. Additionally, drug products were found to be stored outside their specified temperature ranges.

Company: HP Halden Pharma AS
Inspection Date: May 10, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Kevin P. Regan (GDUFA Pharmaceutical Investigator)
Alan P. Kurtzberg (Consumer Safety Officer (Drug Specialist))

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ID · 6fa4a79b-8d45-42e4-8815-d40ba3827ba2