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

Source: https://www.keypedia.com/records/483/basf-as-avd-sandefjord/9555c292-ac78-4a38-b8b0-3b3847d66e1d

> 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: Baltimore District Office
- Summary: The U.S. Food and Drug Administration (FDA) issued a Form 483 to BASF AS avd Sandefjord, an API manufacturer located in Sandefjord, Norway, following an inspection conducted from January 20 to January 24, 2025. This document outlines observations of objectionable conditions and practices related to the company's compliance with manufacturing regulations.Two primary observations were noted. Firstly, the FDA found that deviation investigations were not thoroughly conducted. Specifically, root causes were not adequately identified, and there was a lack of follow-up to ensure identified corrective actions were completed or verified. Examples included an investigation (DEV 14235) where a modified manufacturing parameter was not verified as utilized, and another (DEV 15499) which failed to identify the root cause of an initial error, focusing instead on subsequent operator actions without formal remedial training or documented corrective action completion.Secondly, the inspection revealed that equipment Preventative Maintenance (PM) events were not performed as scheduled. The SAP Calibration and Maintenance Tracker showed multiple instances where scheduled PM activities were not completed by their target dates, and no written justifications were provided for these delays or unaccomplished tasks. This included PM for specific equipment and cleaning activities for plant equipment H6906 and H6606, which remained overdue without explanation.These observations indicate a need for BASF AS avd Sandefjord to enhance its quality systems, particularly regarding deviation management and equipment maintenance, to align with the Federal Food, Drug, and Cosmetic Act and Good Manufacturing Practices. The company is expected to implement comprehensive corrective and preventive actions to address these findings and prevent recurrence.

## Related Documents

- [483 - 2025-01-24](https://www.keypedia.com/records/483/basf-as-avd-sandefjord/97b80de6-91fe-45d7-bccf-6b4740079fe9)

## Related Officers

- [Junho Pak, Investigator](https://www.keypedia.com/people/junho-pak-investigator/9d0f81de-8e18-4423-9b27-efe686d55c39)

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

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa