# FDA 483 - Advanced Breath Diagnostics, LLC dba Spirulina Production Facility - March 09, 2026

Source: https://www.keypedia.com/records/483/advanced-breath-diagnostics-llc-dba-spirulina-production-facility/ff3dd87e-a213-4159-bd6a-53073b94e48c

> FDA 483 for Advanced Breath Diagnostics, LLC dba Spirulina Production Facility on March 09, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Breath Diagnostics, LLC dba Spirulina Production Facility
- Inspection Date: 2026-03-09
- Product Type: device
- Office Name: New Orleans District Office
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/nikki-s-bryant/fe859d4f-23a6-4bc9-94c6-5b3c3fe8d99a)

Company: https://www.keypedia.com/companies/advanced-breath-diagnostics-llc-dba-spirulina-production-facility/69bbaded-cc1a-414e-9039-8172fb38e44f

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea