Overview
- 9 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-10-31.
At a glance
Inspections
9
Form 483s
4
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Oct 2024 – 31 Oct 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Nov 2021 – 4 Nov 2021 | Medical Devices & Rad Health | Clean | |
| 18 Jul 2019 | Medical Devices & Rad Health | Clean | |
| 3 Jun 2016 | Medical Devices & Rad Health | Clean | |
| 9 Apr 2015 – 21 Apr 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Jan 2013 | Not recorded | Clean | |
| 26 Jan 2011 | Not recorded | 483 | View 483 → |
| 14 Oct 2008 | Not recorded | 483 | On file |
| 25 Jul 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Oct 2024
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Jacqueline S Warner
Investigators
FDA investigators tied to this site in the record.
Kwong P Lee3 insp.
Andrew J Garufi2 insp.
Jacqueline S Warner1 insp.
Preston M Lee1 insp.
Dipesh K Shah1 insp.
Nazmul Hassan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Advanced Back Technologies, Inc.'s 4 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat