# FDA 483 - BASF AS avd Sandefjord - January 24, 2025

Source: https://www.globalkeysolutions.net/records/483/basf-as-avd-sandefjord/97b80de6-91fe-45d7-bccf-6b4740079fe9

> FDA 483 for BASF AS avd Sandefjord on January 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BASF AS avd Sandefjord
- Inspection Date: 2025-01-24
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of BASF AS avd Sandefjord, an API manufacturer, revealed two significant observations. The firm failed to conduct thorough deviation investigations, specifically regarding root cause identification and verification of corrective actions. Additionally, scheduled equipment preventative maintenance events were not performed as scheduled, and no justifications were provided for these delays.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/basf-as-avd-sandefjord/1b76cb86-c9db-45f9-bfdd-e2eaec2a67b7

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