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Medical Devices / Inspections and Audits

Preservation Solutions Draws FDA Warning for GMP Violations

Sept. 29, 2017

Preservation Solutions, a Wisconsin-based provider of organ preservation and transplant solutions, was hit with an FDA warning letter for GMP nonconformities.

The agency sent the warning letter after it found the company’s response to observations in a Form 483 report — issued after a facility inspection conducted from April 21 through May 19 — to be inadequate.

The FDA investigator noted that the required validations of media fills, stability, equipment, clean room and processes were either not being done or were inadequate. For example, the firm’s procedure for cleaning its cleanrooms was not validated to prove the method was adequate or acceptable.

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