FDA Inspection 806708 — Advanced Breath Diagnostics, LLC
The FDA completed an inspection of Advanced Breath Diagnostics, LLC on October 19, 2012 in Brentwood, TN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 19, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Brentwood, TN (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 3048 | 21 CFR 812.150(b)(5) | Sponsor progress reports for non-significant risk study |
| 7006 | 21 CFR 812.43(c)(5) | No financial disclosure info in investigator agreement |
| 7017 | 21 CFR 812.150(b)(7) | Sponsor final report for non-significant risk study |