483
Multisource Manufacturing LLCMultisource Manufacturing LLC – FDA 483, Nov 8, 2017
Record Details
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.
- Office
- Denver District Office
- Person
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ID · 61af7e4e-17b9-4b80-aed3-cf920e06fd9f
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