# FDA EIR - Csl Plasma - March 18, 2022

Source: https://www.keypedia.com/records/eir/csl-plasma/2c0b868e-17b0-480c-acb8-a0ef7d952af7

> FDA EIR for Csl Plasma on March 18, 2022. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Csl Plasma
- Inspection Date: 2022-03-18
- Product Type: Biologics
- Office Name: Cincinnati District Office
- Summary: A routine surveillance inspection of CSL Plasma's facility in Columbus, OH, was conducted by the FDA from March 15 to March 18, 2022. This inspection was performed under Compliance Program 7342.002 for Source Plasma Establishments and followed ORA Field Alert #57, which outlines protocols for conducting inspections during the COVID-19 pandemic. The primary focus areas included the company's Quality Assurance and Product Collection and Processing Systems.

During the four-day inspection, investigators reviewed extensive documentation such as standard operating procedures, deviation records, temperature logs, adverse reaction reports, and observed critical operations like donor screening, physical examinations, plasma collection procedures, and storage. CSL Plasma collects source plasma for further manufacture into various medical products and operates a special immunization program.

Significantly, the inspection concluded with no regulatory violations or issues identified. No FDA Form 483, "Inspectional Observations," was issued to the company, and no discussion items were noted during the closeout meeting with management. This satisfactory outcome indicates the facility's compliance with established regulatory standards for quality and safety. Consequently, no specific corrective actions were required from CSL Plasma following this inspection.

## Related Documents

- [EIR - 2022-03-18](https://www.keypedia.com/records/eir/csl-plasma/c89f0297-dc32-4a8c-b932-b3383e63730c)

## Related Officers

- [Nisha C. Patel](https://www.keypedia.com/people/nisha-c-patel/1b38764f-c7bc-4f90-9af1-54989ad6d59c)
- [recipient](https://www.keypedia.com/people/angela-l-funk/6b995a92-8690-44c8-bf47-aeb1efa445fa)
- [company_representative](https://www.keypedia.com/people/christine-thomas/d1809c1e-9b42-4bfa-80c9-7172bf38598e)
- [company_representative](https://www.keypedia.com/people/stacie-f-andrews/e76a3591-bda3-42fc-8c68-92da3cf72641)

Company: https://www.keypedia.com/companies/csl-plasma/165f5429-1f8d-4d46-b9e0-2677052bb35b

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22