483
Space Maintainers LabFDA 483 - Space Maintainers Lab - September 17, 2021
Record Details
An FDA inspection of Space Maintainers Lab in Chatsworth, CA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm was cited for failing to establish adequate procedures for design control, process control, and employee training. These issues indicate a lack of fundamental controls necessary for ensuring medical device quality and compliance.
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ID · a21031d1-209b-4544-aa01-61ba53dc87f4