Advanced Breath Diagnostics, LLC dba
FDA inspection history in Brentwood, Tennessee, 2016
- 1
- Form 483
Every document, by year
- Form 483
2016: one amended 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One amended 483, at Brentwood, Tennessee.
Cited most
Across all Advanced Breath Diagnostics, LLC dba observations on file
- 21 CFR 820.100Corrective and preventive action2
- 21 CFR 820.70Production and process controls2
- 21 CFR 820.90Nonconforming product2
- 21 CFR 806.20Records of corrections and removals not required to be reported1
- 21 CFR 820.40Document controls1
The complete Advanced Breath Diagnostics, LLC dba file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Brentwood, Tennessee
One amended 483 · 2016 · 10 observations
Latest: Form 483, Sep 14, 2016 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-09-14 | Amended 483 Amended 483 | Brentwood, Tennessee | 10 | $99 |
Investigators on these documents
FEI number 3009091796 · most recent document Sep 14, 2016
About Advanced Breath Diagnostics, LLC dba
How many FDA Form 483s has Advanced Breath Diagnostics, LLC dba received?
FDA Intel has 1 Form 483 on file for Advanced Breath Diagnostics, LLC dba; the most recent is dated Sep 14, 2016.
When was Advanced Breath Diagnostics, LLC dba last inspected by FDA?
The most recent FDA inspection document on file for Advanced Breath Diagnostics, LLC dba is a Form 483 dated Sep 14, 2016, for the site in Brentwood, Tennessee.
What did FDA cite at Advanced Breath Diagnostics, LLC dba?
The regulations cited most in the observations on file for Advanced Breath Diagnostics, LLC dba are 21 CFR 820.100 (Corrective and preventive action), 2 times; 21 CFR 820.70 (Production and process controls), 2 times; 21 CFR 820.90 (Nonconforming product), 2 times.