# FDA 483 - CSL Plasma Inc. - March 21, 2019

Source: https://www.globalkeysolutions.net/records/483/csl-plasma-inc/89b5b51e-59f3-4f48-b8d0-188bdbfa97f2

> FDA 483 for CSL Plasma Inc. on March 21, 2019. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: CSL Plasma Inc.
- Inspection Date: 2019-03-21
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of CSL Plasma, Inc. in Linden, New Jersey, from March 19-21, 2019, revealed three observations related to the firm's Quality Department failing to consistently follow its standard operating procedures. Deficiencies included inadequate donor contact attempts for deferred donors, failure to inspect damaged supplies, and untimely completion of overharvest investigations. These issues indicate a need for improved adherence to internal quality systems to ensure donor safety and product suitability.

## Related Officers

- [Amy W. Yan-Mai](https://www.globalkeysolutions.net/people/amy-w-yan-mai/00551315-3a03-4327-ab3a-71de5c1577d4)
- [Camilla S. Smith](https://www.globalkeysolutions.net/people/camilla-s-smith/c93fccaf-ccf1-45d7-8cb3-9ef57ec9895c)

Company: https://www.globalkeysolutions.net/companies/csl-plasma-inc/260b293e-3e84-4622-a508-d759ece8acdb

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd