# FDA 483 - CSL Plasma Inc. - February 15, 2022

Source: https://www.globalkeysolutions.net/records/483/csl-plasma-inc/53c51154-fd17-4bdb-a74c-d5f043c4ddb6

> FDA 483 for CSL Plasma Inc. on February 15, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Plasma Inc.
- Inspection Date: 2022-02-15
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: CSL Plasma Inc. in Dallas, TX, was cited for three significant observations related to plasma collection and record-keeping practices. The inspection revealed failures in reporting adverse donor reactions, adhering to standard operating procedures for quarantining HCV-positive plasma units, and maintaining accurate and traceable donor records. These issues indicate a lack of robust quality control and documentation practices in critical areas of blood component collection.

## Related Officers

- [Elmina E Akwo](https://www.globalkeysolutions.net/people/elmina-e-akwo/ecd9066d-1647-4765-ad86-dbe5280241c5)

Company: https://www.globalkeysolutions.net/companies/csl-plasma-inc/2d16e0fd-451b-48ba-aeab-ce313175ab7d

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