# FDA 483 - Vistin Pharma AS avd Kragero Fikkjebakke - January 31, 2025

Source: https://www.globalkeysolutions.net/records/483/vistin-pharma-as-avd-kragero-fikkjebakke/6c706c1d-6343-4892-b80c-3040e3d034c1

> FDA 483 for Vistin Pharma AS avd Kragero Fikkjebakke on January 31, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vistin Pharma AS avd Kragero Fikkjebakke
- Inspection Date: 2025-01-31
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Vistin Pharma, an API manufacturer in Samidal, Norway, revealed significant deficiencies in their quality system. Observations included inadequate deviation investigations and corrective actions, insufficient testing of recycled solvents used in drug substance production, and a lack of written procedures for reporting product quality defects, specifically Field Alert Reports, to health authorities within specified timelines.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)

Company: https://www.globalkeysolutions.net/companies/vistin-pharma-as-avd-kragero-fikkjebakke/6acc0a66-9192-481c-a1bf-4d4d0cbf68e7

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