Advanced Back Technologies, Inc
Form 483 issued October 31, 2024 · Syosset, New York
- Inspection
- Oct 29 – Oct 31, 2024
- Investigator
- Jacqueline S. Warner
- Observations
- 4
- Pages
- 5
- FEI number
- 3004755153
In short: On October 31, 2024, FDA issued a Form 483 with 4 observations to Advanced Back Technologies, Inc in Syosset, New York (FEI 3004755153) after an inspection that ran Oct 29 – Oct 31, 2024. The investigator was Jacqueline S. Warner. Most observations concern records & documents and production & process controls.
At a glance
Observations span 4 systems, led by records & documents.
What FDA observed
Preview: the opening words of each observation- 01
A device history record has…
- 02
There is no agreement with contractors to notify you of changes in…
- 03
Procedures for collective and preventive action have not been adequately established. Decompression System…
- 04
Procedures for design change have…
This inspection in context
Jacqueline S. Warner
7 documents · 2008–2024
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in New York.
The firmAdvanced Back Technologies, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.184
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advanced Back Technologies, Inc?
FDA listed 4 observations on this Form 483, mostly about records & documents, production & process controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Advanced Back Technologies, Inc?
Jacqueline S. Warner is named on this Form 483, for the inspection of Oct 29 – Oct 31, 2024. Each investigator has a profile showing what they cite most.
When was Advanced Back Technologies, Inc inspected by FDA?
The inspection ran Oct 29 – Oct 31, 2024, and the Form 483 is dated October 31, 2024.
How do I get the full Form 483 for Advanced Back Technologies, Inc?
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.