Overview
- 9 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-05.
At a glance
Inspections
9
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Feb 2026 – 5 Feb 2026 | Medical Devices & Rad Health | Clean | |
| 26 Oct 2021 – 27 Oct 2021 | Medical Devices & Rad Health | Clean | |
| 7 May 2018 – 9 May 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Mar 2013 – 4 Apr 2013 | Medical Devices & Rad Health | 483 | On file |
| 14 Oct 2011 | Not recorded | 483 | On file |
| 26 Apr 2010 | Not recorded | 483 | View 483 → |
| 18 Jun 2007 | Not recorded | Clean | |
| 22 Jan 2004 | Not recorded | Clean | |
| 27 Apr 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 May 2018
21 CFR 803.17(b)(1)
Info evaluated to determine if event was reportable
Cited by Sonya L Karsik
26 Apr 2010
21 CFR 820.20(b)(1)
Responsibility, authority and independence
Cited by Truong X Nguyen, Vickie L Anderson
Investigators
FDA investigators tied to this site in the record.
Kevin N Tran2 insp.
Sonya L Karsik1 insp.
Juanita Banuelos1 insp.
Joey V Quitania1 insp.
Courtney N Long1 insp.
Truong X Nguyen1 insp.
Vickie L Anderson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.150(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.60 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(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 Teco Diagnostics, 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