FDA Inspection
Advanced Breath Diagnostics, LLC dba Spirulina Production FacilityAdvanced Breath Diagnostics, LLC dba Spirulina Production Facility – FDA Inspection, Mar 9, 2026
Record Details
This FDA Inspection record concerns Advanced Breath Diagnostics, LLC dba Spirulina Production Facility, with an inspection on March 9, 2026, issued by the New Orleans District Office, covering medical devices & rad health.
- Inspection Date
- March 9, 2026
- Product Type
- Medical Devices & Rad Health
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ID · dbcda414-c71d-4a62-a89a-bbb4de94285b
Inspection Facts
- Inspection number
- 1306804
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
FDA Citations
1- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
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Other FDA inspections of Advanced Breath Diagnostics, LLC dba Spirulina Production Facility
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2025 | Not classified | New Orleans District Office | |
| May 23, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 20, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Advanced Breath Diagnostics, LLC dba Spirulina Production Facility
- FDA Inspection 1273492 - 2025-05-23
- FDA Inspection 1206620 - 2023-05-23
- FDA Inspection 859263 - 2013-11-20
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