# FDA 483 - Octapharma Plasma, Inc. - May 02, 2019

Source: https://www.keypedia.com/records/483/octapharma-plasma-inc/1726292c-bf26-44d6-ad2b-cda52b341a03

> FDA 483 for Octapharma Plasma, Inc. on May 02, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Octapharma Plasma, Inc.
- Inspection Date: 2019-05-02
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: Octapharma Plasma, Inc. in Dallas, TX, received a Form 483 for failing to adequately assess donor medical history during plasma donations. The firm did not identify factors such as the use of over-the-counter medications, which could adversely affect donor health or the safety and purity of the donated plasma. This indicates a significant lapse in donor screening procedures.

## Related Documents

- [483 - 2024-03-22](https://www.keypedia.com/records/483/octapharma-plasma-inc/20372d7d-8e3e-4efc-8f53-90b3f7d2fe76)

## Related Officers

- [investigator](https://www.keypedia.com/people/everard-a-irish/840ad8d1-1e8a-4ade-9b3b-64f654754d17)

Company: https://www.keypedia.com/companies/octapharma-plasma-inc/4c957300-d2bd-437e-acf8-5b0132c63267

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9