# FDA 483 - Octapharma Plasma Inc - January 10, 2024

Source: https://www.keypedia.com/records/483/octapharma-plasma-inc/300e73f6-5f91-483a-b9c1-7078fb24c82f

> FDA 483 for Octapharma Plasma Inc on January 10, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Octapharma Plasma Inc
- Inspection Date: 2024-01-10
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Octapharma Plasma Inc.'s plasmapheresis center in Cincinnati, OH, revealed a significant issue with adherence to written standard operating procedures. Specifically, employees failed to consistently follow procedures for visually inspecting refractometers for red blood cells during donor screening, potentially impacting the quality and safety of collected blood components. This indicates a breakdown in procedural compliance during critical donor evaluation steps.

## Related Officers

- [Jennifer L. Sheehan](https://www.keypedia.com/people/jennifer-l-sheehan/a49c628d-6eba-4b52-bafc-70785b9ba75e)

Company: https://www.keypedia.com/companies/octapharma-plasma-inc/1a23d319-a8d1-44c5-a19c-90efa35ef2f8

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22