# FDA 483 - CSL Plasma Inc. - June 15, 2023

Source: https://www.globalkeysolutions.net/records/483/csl-plasma-inc/90dd5a9b-d009-49b3-8022-07d017023311

> FDA 483 for CSL Plasma Inc. on June 15, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Plasma Inc.
- Inspection Date: 2023-06-15
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: CSL Plasma Inc. in Henrico, VA, a plasma center, was cited for failing to thoroughly investigate unexplained discrepancies during an FDA inspection. The firm did not investigate 27 temperature readings that exceeded the set point for a freezer used to store collected plasma. This indicates a lapse in adherence to established work instructions for temperature excursions and quality control.

## Related Officers

- [Charles D. Boison](https://www.globalkeysolutions.net/people/charles-d-boison/b128f4a3-c1b1-409f-9291-27deb111d1e5)

Company: https://www.globalkeysolutions.net/companies/csl-plasma-inc/9cd0d064-5439-47bd-8433-26da36904c9d

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64