# Isteka – FDA 483, Jan 29, 2026

Source: https://www.keypedia.com/records/483/isteka/2a3920e2-87bc-4516-a5fa-153de480c10a

> FDA 483 for Isteka on January 29, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Isteka
- Inspection Date: 2026-01-29
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [Investigator](https://www.keypedia.com/people/karen-a-briggs/3e77d364-25ea-48c7-87f4-36f3e170bfb5)

Company: https://www.keypedia.com/companies/isteka/e616606c-26cf-4abf-8095-8045b5ee79f1

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8