# FDA 483 - Octapharma Produktionsgesellschaft Deutschland mbH - June 11, 2024

Source: https://www.globalkeysolutions.net/records/483/octapharma-produktionsgesellschaft-deutschland-mbh/57feac11-8e09-4ec5-b3a0-55e3a9f59594

> FDA 483 for Octapharma Produktionsgesellschaft Deutschland mbH on June 11, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Octapharma Produktionsgesellschaft Deutschland mbH
- Inspection Date: 2024-06-11
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: Octapharma Produktionsgesellschaft Deutschland mbH in Springe, Germany, was cited for significant deficiencies across its manufacturing operations, primarily concerning inadequate computer system validation and control, and a weak quality system. The inspection revealed issues with automated system qualification, unauthorized batch release, insufficient deviation investigations, untimely CAPA closures, and neglected equipment maintenance. These findings indicate a systemic lack of control over critical manufacturing processes and quality assurance.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/octapharma-produktionsgesellschaft-deutschland-mbh/9abcde7e-9994-46b8-891a-a968f0451c79)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/priscilla-m-pastrana/170080d1-49da-42d7-8615-c774cac9f7ec)
- [investigator](https://www.globalkeysolutions.net/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)

Company: https://www.globalkeysolutions.net/companies/octapharma-produktionsgesellschaft-deutschland-mbh/6a1a14b1-f958-4ba6-b283-5c92ef67a783

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321