# FDA 483 - CSL Plasma Inc. - July 12, 2024

Source: https://www.globalkeysolutions.net/records/483/csl-plasma-inc/60648ac5-3982-4093-901d-53d940363b58

> FDA 483 for CSL Plasma Inc. on July 12, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Plasma Inc.
- Inspection Date: 2024-07-12
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: CSL Plasma Inc. in Saginaw, MI, received a Form 483 following an inspection from July 9-12, 2024. The inspection revealed significant insanitary conditions, including widespread insect infestation with dead and alive beetles in multiple rooms and structural deficiencies like air gaps. These findings indicate a failure to maintain clean and orderly facilities, raising concerns about product integrity and safety.

## Related Officers

- [Gabryelle J. Solverud](https://www.globalkeysolutions.net/people/gabryelle-j-solverud/29c4452f-2f7a-4325-8f8d-7046fcb4690f)

Company: https://www.globalkeysolutions.net/companies/csl-plasma-inc/2e298b07-8114-4d95-9d7b-6ff6f56661c9

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0