# FDA 483 - Octapharma Plasma Inc - December 11, 2025

Source: https://www.keypedia.com/records/483/octapharma-plasma-inc/71fc6cd8-98c9-471f-bb67-fac963c5a712

> FDA 483 for Octapharma Plasma Inc on December 11, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Octapharma Plasma Inc
- Inspection Date: 2025-12-11
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Octapharma Plasma Inc, a plasmapheresis center in Santa Fe Springs, CA, was cited for deficiencies in its donor screening process. The firm's standard operating procedures for determining donor eligibility, specifically regarding blood pressure measurement, were found to be incomplete. Furthermore, staff were observed failing to adhere to proper blood pressure measurement techniques, potentially compromising the accuracy of donor eligibility assessments.

## Related Documents

- [483 - 2025-12-11](https://www.keypedia.com/records/483/octapharma-plasma-inc/98d4c67b-9fa0-41ea-b834-f9bef9f8d3a0)

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/maurine-fadlalla/519e6e71-a50a-43b5-b41a-2249ec9afdd5)

Company: https://www.keypedia.com/companies/octapharma-plasma-inc/04d5feb0-1f6a-4106-9810-fcbbb54d51f9

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6