483
Multisource Manufacturing LLCFDA 483 - Multisource Manufacturing LLC - November 08, 2017
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An FDA inspection of MultiSource Manufacturing LLC in Lafayette, CO, a medical device manufacturer, revealed three significant observations. The firm was cited for failing to adequately validate automated manufacturing processes, establish proper procedures for in-process product acceptance and control, and implement sufficient corrective and preventive action procedures. These issues indicate deficiencies in the firm's quality management system.
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