483
Core Health and Fitness, LLCCore Health and Fitness, LLC – FDA 483, Jul 30, 2026
Record Details
An FDA inspection of Diversified Healthcare Development LLC in Independence, VA, a manufacturer, revealed two significant observations. The firm failed to adequately document procedures for controlling design and development changes, particularly for software, and did not properly monitor and control outsourced processes by failing to evaluate critical suppliers according to written procedures. These issues indicate deficiencies in the firm's quality system controls.
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ID · f681d4b0-d65c-45c4-a55b-703aaffe68de
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