Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-12-05.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Dec 2024 – 5 Dec 2024 | Medical Devices & Rad Health | Clean | |
| 28 Mar 2022 – 8 Apr 2022 | Medical Devices & Rad Health | Clean | |
| 3 Dec 2019 – 6 Dec 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Jul 2013 – 14 Aug 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Jun 2010 | Not recorded | Clean | |
| 28 May 2009 | Not recorded | WL | View 483 → |
| 9 Mar 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Dec 2019
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Jude C Dike
6 Dec 2019
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Jude C Dike
Investigators
FDA investigators tied to this site in the record.
Jude C Dike3 insp.
Lindsey L Kirsh1 insp.
James M Simpson1 insp.
Joseph A Morkunas1 insp.
Cynthia A Harris1 insp.
Erin L Mcfiren1 insp.
Tania E Vizcaino1 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 | 2x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(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(e) | 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(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 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Tetracore, Inc.'s 3 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