483
CME America, LLCCME America, LLC – FDA 483, Apr 23, 2018
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.
View Company Profile
ID · 5f321213-5720-49da-91b0-79715059f2cf
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.