483
Advanced Breath Diagnostics, LLC dba Spirulina Production FacilityAdvanced Breath Diagnostics, LLC dba Spirulina Production Facility – FDA 483, Mar 9, 2026
Record Details
An FDA inspection of Advanced Breath Diagnostics LLC in Franklin, TN, revealed a significant deficiency in their risk management processes for product realization. The firm failed to adequately document potential contamination hazards for crackers used in their Class III GEBT kits, including risks from manufacturing practices and airborne contaminants. This indicates a serious concern regarding patient safety and product quality.
- Inspection date
- March 9, 2026
- Product type
- device
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ID · ff3dd87e-a213-4159-bd6a-53073b94e48c
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