# FDA 483 - CSL Plasma Inc. - March 10, 2022

Source: https://www.keypedia.com/records/483/csl-plasma-inc/277f40f5-28bc-4094-b12b-d1b128d7ef3c

> FDA 483 for CSL Plasma Inc. on March 10, 2022. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: CSL Plasma Inc.
- Inspection Date: 2022-03-10
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: CSL Plasma Inc. in Normal, IL, a source plasma center, was cited for three observations during an FDA inspection. The firm failed to adequately investigate a trend of unsuitable donor addresses and did not properly qualify new electronic temperature monitoring systems for plasma storage freezers before use. Additionally, the firm failed to maintain complete temperature records for plasma storage freezers, indicating deficiencies in quality system controls and record-keeping.

## Related Officers

- [Melisa A Healy](https://www.keypedia.com/people/melisa-a-healy/367f34ad-0afe-4b6e-87f9-327ba9313e95)
- [issuing_officer](https://www.keypedia.com/people/jennifer-a-kemp/51aa8f2f-ba64-47d3-aa06-b4595b3d15c8)

Company: https://www.keypedia.com/companies/csl-plasma-inc/6f42955a-e4f5-4f85-a776-9640ec47f6fc

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669