483
Global Health Solutions LLC dba Turn TherapeuticsGlobal Health Solutions LLC dba Turn Therapeutics – FDA 483, Jul 3, 2019
Record Details
Global Health Solutions LLC dba Turn Therapeutics, a medical device manufacturer in Calabasas, CA, was inspected by the FDA. The inspection revealed a significant deficiency in their quality system, specifically the failure to establish design control procedures for their medical devices. This indicates a fundamental lack of documented processes for design and development activities.
- Inspection date
- July 3, 2019
- Product type
- device
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ID · 78733c00-99b4-4584-a7ee-64a528931285
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