# FDA 483 - Octapharma S.A.S. - Unknown Date

Source: https://www.keypedia.com/records/483/octapharma-sas/352cd8a6-3db9-45e7-88cd-5ac5d080427d

> FDA 483 for Octapharma S.A.S. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Octapharma S.A.S.
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: An FDA inspection of Octapharma S.A.S. in Lingolsheim, France, a blood product manufacturer, revealed significant deficiencies in their quality system. The firm was cited for inadequate investigations into unexplained discrepancies, untimely implementation of corrective and preventive actions (CAPAs), and incomplete process validation. Additionally, deficient procedures and a lack of change control for recurring human error deviations were observed, indicating a need for improved manufacturing controls.

## Related Officers

- [Silvia Waass](https://www.keypedia.com/people/silvia-waass/295a51f6-2a79-4a99-afa2-255c423cd35a)
- [investigator](https://www.keypedia.com/people/christian-d-lynch/3b2748d3-3800-4538-939d-71a33dca0b2d)
- [Jay Ellermann](https://www.keypedia.com/people/jay-ellermann/90c49a43-f04b-4d45-8c0d-84bd12e39f6a)

Company: https://www.keypedia.com/companies/octapharma-sas/9bce8830-4190-4ec9-929c-63a604b86c58

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