Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-09-01.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Aug 2021 – 1 Sep 2021 | Medical Devices & Rad Health | Clean | |
| 15 Aug 2017 – 21 Aug 2017 | Medical Devices & Rad Health | Clean | |
| 20 Feb 2014 – 17 Mar 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Feb 2013 – 11 Apr 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Feb 2012 | Not recorded | 483 | View 483 → |
| 2 Nov 2009 | Not recorded | Clean | |
| 5 Nov 2008 | Not recorded | 483 | View 483 → |
| 10 Nov 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Mar 2014
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Kirtida Patel
17 Mar 2014
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Kirtida Patel
Investigators
FDA investigators tied to this site in the record.
Kimberly M Lichter2 insp.
Kevin N Tran1 insp.
Alexandria L Capuano1 insp.
Sonya L Karsik1 insp.
Kirtida Patel1 insp.
Juanita Banuelos1 insp.
Herminio C Francisco1 insp.
Jocelyn E Massey1 insp.
Mei-Chen Mu1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind TENEX HEALTH'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