# FDA 483 - Octapharma Plasma, Inc. - March 22, 2024

Source: https://www.globalkeysolutions.net/records/483/octapharma-plasma-inc/20372d7d-8e3e-4efc-8f53-90b3f7d2fe76

> FDA 483 for Octapharma Plasma, Inc. on March 22, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Octapharma Plasma, Inc.
- Inspection Date: 2024-03-22
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Octapharma Plasma, Inc. in Dallas, TX, a source plasma center, revealed a significant quality control issue related to equipment calibration. The firm failed to ensure that weights used for plasma collection were calibrated against the proper weight standard, leading to an inability to determine equipment tolerance for critical devices. This lapse indicates a failure to comply with official requirements for equipment performance.

## Related Documents

- [483 - 2019-05-02](https://www.globalkeysolutions.net/records/483/octapharma-plasma-inc/1726292c-bf26-44d6-ad2b-cda52b341a03)

## Related Officers

- [Ramon L. Gonzalez-Prieto](https://www.globalkeysolutions.net/people/ramon-l-gonzalez-prieto/f03487d2-7c8c-407f-8270-a838f7a7d127)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab