# FDA 483 - Octapharma Plasma, Inc. - March 07, 2023

Source: https://www.keypedia.com/records/483/octapharma-plasma-inc/dd48a0dd-1e05-4b15-85de-0a040eacc7b5

> FDA 483 for Octapharma Plasma, Inc. on March 07, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Octapharma Plasma, Inc.
- Inspection Date: 2023-03-07
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Octapharma Plasma, Inc. in Houston, TX, revealed significant issues in their donor testing and notification processes. The firm failed to consistently provide correct test results for relevant transfusion-transmitted infections (RTTI) to deferred donors, including HIV and RPR results. Additionally, the company did not adhere to its own Standard Operating Procedure for donor notification and counseling documentation, making it impossible to verify what information was provided to donors.

## Related Officers

- [Christopher Sy](https://www.keypedia.com/people/christopher-sy/429ca249-f950-43cc-b055-4b9b93bfba18)

Company: https://www.keypedia.com/companies/octapharma-plasma-inc/7654aae9-2d4d-4cc3-bfda-aa7c48fcb4ab

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd