Advanced Back Technologies, Inc
Form 483 issued April 21, 2015 · Hauppauge, New York
- Inspection
- Apr 9 – Apr 21, 2015
- Investigator
- Andrew Garufi
- Observations
- 2
- Pages
- 2
- FEI number
- 3004755153
In short: On April 21, 2015, FDA issued a Form 483 with 2 observations to Advanced Back Technologies, Inc in Hauppauge, New York (FEI 3004755153) after an inspection that ran Apr 9 – Apr 21, 2015. The investigator was Andrew Garufi. Most observations concern management controls and cAPA; the most-cited regulation is 21 CFR 820.22 (quality audit).
At a glance
Management controls and capa account for 2 of 2 observations.
Most cited: 21 CFR 820.22 (1×) · 820.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Quality audits were not performed at defined intervals to determine whether the quality system activities and…
- 02
Corrective and preventive action activities and/or results have…
This inspection in context
Andrew Garufi
11 documents · 2015–2025
Cites 820.80(b) (receiving, in-process, and finished device acceptance) 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 820.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advanced Back Technologies, Inc?
FDA listed 2 observations on this Form 483, mostly about management controls and cAPA. The most-cited regulation is 21 CFR 820.22 (quality audit). The opening words of each observation are shown on this page.
Who inspected Advanced Back Technologies, Inc?
Andrew Garufi is named on this Form 483, for the inspection of Apr 9 – Apr 21, 2015. Each investigator has a profile showing what they cite most.
When was Advanced Back Technologies, Inc inspected by FDA?
The inspection ran Apr 9 – Apr 21, 2015, and the Form 483 is dated April 21, 2015.
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.