483
IstekaIsteka – FDA 483, Jan 29, 2026
Record Details
An FDA inspection of Isteka ehf., an API manufacturer in Reykjavik, Iceland, revealed significant deficiencies across multiple areas. Observations included inadequate data integrity controls for computerized systems, failure to establish identity for incoming raw materials, and issues with equipment qualification. Additionally, the firm failed to ensure adequate monitoring of storage conditions for temperature-sensitive materials.
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ID · 2a3920e2-87bc-4516-a5fa-153de480c10a
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