# FDA 483 - Octapharma Plasma Inc - March 24, 2022

Source: https://www.keypedia.com/records/483/octapharma-plasma-inc/540d1771-12de-421b-9c08-a17240270d49

> FDA 483 for Octapharma Plasma Inc on March 24, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Octapharma Plasma Inc
- Inspection Date: 2022-03-24
- Product Type: biologics
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Octapharma Plasma Inc in Baton Rouge, LA, a source plasma center, revealed a significant failure to perform thorough investigations into unexplained discrepancies. The firm consistently failed to identify root causes and implement effective corrective and preventative actions for recurring issues, including high red blood cell loss rates and minor deviation error rates over an extended period. This indicates a systemic weakness in the firm's quality management and deviation investigation processes.

## Related Officers

- [Fabian N. Chaparro-rodriguez](https://www.keypedia.com/people/fabian-n-chaparro-rodriguez/f14fd931-0830-4a84-a287-2dd85e40195d)

Company: https://www.keypedia.com/companies/octapharma-plasma-inc/948e6257-d6a8-4bd2-9bfe-9f5bde6829ce

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea