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# Quality System Issues at Preservation Solutions
- URL: https://www.fdaweb.com/quality-system-issues-at-preservation-solutions/
- Published: 2017-09-19T12:00:00.000Z
- Updated: 2026-09-14T22:51:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139660

A 4/21-5/19 FDA inspection at Preservation Solutions, Elkhorn, WI, found Quality System regulation issues in the firm’s manufacturing of organ transplant preservation solutions, which are regulated as medical devices. Violations cited in an 8/21 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm575367.htm?ref=fdaweb.com) were:

- failing to adequately validate, according to established procedures, a process whose results cannot be fully verified by subsequent inspection and test;
- failing to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failing to adequately establish procedures to control environmental conditions;
- failing to adequately establish procedures for acceptance of incoming product; and
- failing to adequately establish procedures for corrective and preventive action.

 The firm’s responses to the inspection observations were inadequate, the letter says. Preservation Solutions was told to respond with a list of the steps it has taken to correct the violations and prevent them from recurring in the future, along with documentation of each step and a timetable for completion.