483
Chase MedicalFDA 483 - Chase Medical - February 25, 2021
Record Details
An FDA inspection of KDL Medical Inc dba Chase Medical, a device manufacturer in Richardson, TX, identified two significant observations. The firm failed to adequately validate the sterilization process for a Class I Sternal Retractor device. Additionally, the company did not implement proper statistical techniques, specifically failing to follow its established sampling plan for receiving inspection of components.
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- Dallas District Office
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ID · 15e30148-471f-4e26-aae5-20603240bcee
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