# Octapharma Plasma Inc – FDA 483, Jul 10, 2026

Source: https://www.keypedia.com/records/483/octapharma-plasma-inc/23b791af-1c32-4ed2-9aa5-cf5c68e8c23c

> FDA 483 for Octapharma Plasma Inc on July 10, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Octapharma Plasma Inc
- Inspection Date: 2026-07-10
- Product Type: biologics
- Office Name: New Jersey District Office
- Summary: During an inspection of Octapharma Plasma Inc in Audubon, NJ, the FDA observed that the firm's plasmapheresis center had inadequate personnel for processing blood and blood components. This deficiency led to a backlog in processing source plasma units, resulting in some units not being frozen within the firm's established Standard Operating Procedure timeframes. These conditions raise concerns about the safety, purity, potency, identity, and effectiveness of the final product.

## Related Officers

- [Kish Bolden](https://www.keypedia.com/people/kish-bolden/e24957d4-927f-40c7-a7ca-860fedce2e3f)

Company: https://www.keypedia.com/companies/octapharma-plasma-inc/91eef912-b5fc-4a98-ac5f-b928e91c58b8

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248