# FDA 483 - Preservation Solutions, Inc. - July 14, 2023

Source: https://www.keypedia.com/records/483/preservation-solutions-inc/0a9b12ea-498c-483b-b081-e25948c0bc01

> FDA 483 for Preservation Solutions, Inc. on July 14, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Preservation Solutions, Inc.
- Inspection Date: 2023-07-14
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Preservation Solutions, Inc. in Elkhorn, WI, a manufacturer of organ transplant preservation solutions, revealed significant and persistent deficiencies. The firm was cited for inadequate environmental control procedures, insufficient validation of aseptic processes, and ineffective corrective and preventive actions. These issues are particularly severe as they are repeat observations from multiple prior inspections and were noted in a 2017 Warning Letter.

## Related Documents

- [WARNING_LETTER - 2017-05-19](https://www.keypedia.com/records/warning_letter/preservation-solutions-inc/5704a2d5-ffd7-4205-9660-fbda6a5251fe)
- [483 - 2021-09-30](https://www.keypedia.com/records/483/preservation-solutions-inc/ecb2f172-5198-4b00-a8c6-8afde0240a1b)
- [483 - 2025-06-06](https://www.keypedia.com/records/483/preservation-solutions-inc/9dda4095-d02b-4dbd-852f-6fbd718d305b)

## Related Officers

- [Nicholas Z. Lu](https://www.keypedia.com/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)

Company: https://www.keypedia.com/companies/preservation-solutions-inc/34f21413-85ce-4be1-8f72-b095f8625b5d

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