Advanced Breath Diagnostics, LLC dba
Amended 483 issued September 14, 2016 · Brentwood, Tennessee
- Inspection
- Aug 30 – Sep 14, 2016
- Investigator
- Bonnie E. Conley
- Observations
- 10
- Pages
- 14
- FEI number
- 3009091796
In short: On September 14, 2016, FDA issued a Amended 483 with 10 observations to Advanced Breath Diagnostics, LLC dba in Brentwood, Tennessee (FEI 3009091796) after an inspection that ran Aug 30 – Sep 14, 2016. The investigator was Bonnie E. Conley. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
CAPA and production & process controls account for 9 of 10 observations.
Most cited: 21 CFR 820.100 (2×) · 820.90 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for corrective and preventive action have…
- 02
Corrective and preventive action activities and/or results…
- 03
Rework and reevaluation activities have not been documented in…
- 04
Procedures for the acceptance of in-process product have…
6 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Bonnie E. Conley
1 document · 2016
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Tennessee.
The firmAdvanced Breath Diagnostics, LLC dba history
The site's inspection history, in date order.
Similar documentsOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Advanced Breath Diagnostics, LLC dba?
FDA listed 10 observations on this Form 483, mostly about cAPA, production & process controls and records & documents. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Advanced Breath Diagnostics, LLC dba?
Bonnie E. Conley is named on this Amended 483, for the inspection of Aug 30 – Sep 14, 2016. Each investigator has a profile showing what they cite most.
When was Advanced Breath Diagnostics, LLC dba inspected by FDA?
The inspection ran Aug 30 – Sep 14, 2016, and the Amended 483 is dated September 14, 2016.
How do I get the full Amended 483 for Advanced Breath Diagnostics, LLC dba?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.