483
MD Labs, LLCMD Labs, LLC – FDA 483, Mar 6, 2025
Record Details
An FDA inspection of MD Labs, LLC, a medical device manufacturer in Westlake Village, CA, identified one significant observation. The firm failed to adequately maintain device history records, specifically by not including or referencing unique device identifiers (UDI) or universal product codes (UPC) as required by their own quality procedures.
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ID · 64bda8c6-74c7-4aa3-986a-9246d91d2715
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