483
ERI GroupFDA 483 - ERI Group - September 20, 2019
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Evergreen Research, Inc. in Golden, CO, was inspected and cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures for environmental controls in cleanrooms, finished device acceptance, and incoming product acceptance. These issues indicate a moderate level of severity, impacting product quality and regulatory compliance.
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ID · 1d88d7b9-15c0-459a-8e08-611a1ffac755