483
Lummacups LLCLummacups LLC – FDA 483, Jan 19, 2023
Record Details
An FDA inspection of Lummaps LLC, a specification developer in Miami, FL, revealed a severe lack of fundamental quality system procedures. The firm failed to establish procedures for critical areas including design control, corrective and preventive actions, purchasing controls, management review, and internal quality audits. This indicates significant deficiencies in their quality management system.
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ID · cef4e1b2-4489-4e26-8788-069cf262c63e
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