Overview
- 9 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-10-18.
At a glance
Inspections
9
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Oct 2023 – 18 Oct 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Jul 2021 – 30 Jul 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Aug 2018 – 24 Aug 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Aug 2017 – 4 Aug 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Sep 2012 | Not recorded | 483 | View 483 → |
| 28 Feb 2012 | Not recorded | 483 | View 483 → |
| 14 Mar 2011 | Not recorded | 483 | View 483 → |
| 5 Dec 2002 | Not recorded | Clean | |
| 4 Jan 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Oct 2023
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Karen M Rodriguez, Karen M Cruz Arenas
18 Oct 2023
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Karen M Rodriguez, Karen M Cruz Arenas
18 Oct 2023
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Karen M Rodriguez, Karen M Cruz Arenas
18 Oct 2023
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Karen M Rodriguez, Karen M Cruz Arenas
18 Oct 2023
21 CFR 820.70(i)
Documentation of software validation
Cited by Karen M Rodriguez, Karen M Cruz Arenas
Investigators
FDA investigators tied to this site in the record.
Lisa A Warner2 insp.
Jason P Aun2 insp.
Leo J Lagrotte2 insp.
Karen M Rodriguez1 insp.
Karen M Cruz Arenas1 insp.
Joshua J Silvestri1 insp.
Emma R Schaefer1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 11x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1002.13 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1002.30(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1040.20(c)(2)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind J&T Health and Wellness LLC's 7 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