# FDA 483 - Octapharma Dessau GmbH - November 08, 2024

Source: https://www.globalkeysolutions.net/records/483/octapharma-dessau-gmbh/febef994-75e8-4a6e-a475-701c2c78c4a2

> FDA 483 for Octapharma Dessau GmbH on November 08, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Octapharma Dessau GmbH
- Inspection Date: 2024-11-08
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: Octapharma Dessau GmbH received a Form 483 for deficiencies in their quality system, specifically regarding biological product deviation reporting, investigation records, batch production documentation, and quality control unit responsibilities. The inspection revealed issues with misaligned SOPs, lack of effectiveness checks for corrective actions, undocumented critical packaging steps, and inadequate qualification of visual inspection equipment. These findings indicate a need for improved procedural alignment and robust quality oversight to ensure product quality and compliance.

## Related Officers

- [Travis S. Bradley](https://www.globalkeysolutions.net/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)
- [Lewis K. Antwi](https://www.globalkeysolutions.net/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)

Company: https://www.globalkeysolutions.net/companies/octapharma-dessau-gmbh/7f93581c-e8bc-4716-954c-165cc9d78962

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