483
CME America, LLCFDA 483 - CME America, LLC - April 23, 2018
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Record Details
CME America, LLC, a medical device manufacturer in Golden, CO, was inspected and found to have significant quality system deficiencies. The firm failed to adequately establish procedures for design verification and validation of its BodyGuard infusion pump system. Additionally, issues were noted in their corrective and preventive action processes and in ensuring purchased products and services conform to specified requirements.
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ID · 5f321213-5720-49da-91b0-79715059f2cf