Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-09.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Mar 2026 – 9 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 May 2025 – 23 May 2025 | Human Drugs | 483 | On file |
| 22 May 2023 – 23 May 2023 | Medical Devices & Rad Health | Clean | |
| 18 Nov 2013 – 20 Nov 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Mar 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Nikki S Bryant
Investigators
FDA investigators tied to this site in the record.
Nikki S Bryant1 insp.
Demario L Walls1 insp.
Inga M Warr1 insp.
Jamie P Webb1 insp.
Bonnie E Conley1 insp.
Marvin D Jones1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Advanced Breath Diagnostics LLC's 3 Form 483s
Recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat