Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-03-02.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Feb 2023 – 2 Mar 2023 | Medical Devices & Rad Health | Clean | |
| 2 Mar 2020 – 4 Mar 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Apr 2017 – 13 Apr 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Oct 2013 – 28 Oct 2013 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Mar 2020
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Richard K Vogel
4 Mar 2020
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Richard K Vogel
13 Apr 2017
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Richard K Vogel
Investigators
FDA investigators tied to this site in the record.
Richard K Vogel3 insp.
Brandon P Thompson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Kalitec Direct, LLC'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