483
HP Halden Pharma ASHP Halden Pharma AS – FDA 483, May 10, 2023
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.
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ID · 6fa4a79b-8d45-42e4-8815-d40ba3827ba2
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