# FDA EIR - Csl Plasma - March 18, 2022

Source: https://www.keypedia.com/records/eir/csl-plasma/c89f0297-dc32-4a8c-b932-b3383e63730c

> 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 plasmapheresis center in Columbus, Ohio, was conducted by the FDA from March 15 to March 18, 2022. This Level 2 inspection, guided by Compliance Program 7342.002 for Source Plasma Establishments, focused on the firm's Quality Assurance and Product Collection and Processing Systems. The inspection included a review of standard operating procedures, deviation records, temperature logs, adverse reactions, and observation of donor screening, physical examinations, consent procedures, plasma collection, processing, and storage. The facility collects Source Plasma for manufacturing injectable and non-injectable products. Key updates since the last inspection included a new freezer temperature monitoring system and an online self-administered health history questionnaire, both reviewed without concerns. Notably, the FDA found no violations during this inspection. A Form FDA-483 (Inspectional Observations) was not issued, and no discussion items or required corrective actions were noted at the closeout meeting. The inspection concluded with no concerns regarding the company's compliance with regulatory standards.

## Related Documents

- [EIR - 2022-03-18](https://www.keypedia.com/records/eir/csl-plasma/2c0b868e-17b0-480c-acb8-a0ef7d952af7)

## 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