FDA Warns Reprocessor Over Validation, Quality Failures

The FDA has warned Zeppessis Reprocessing over numerous GMP deviations at its Garden City, Idaho, facility, including several validation failures. The company reprocesses Stryker’s Neptune 1 and 2 waste management system manifolds. According to the Aug. 9 letter posted recently online, the seven-step cleaning protocol for reprocessing manifolds had not been validated to assure the devices consistently meet requirements.
The GMP Letter