Overview
- 8 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-20.
At a glance
Inspections
8
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2026 – 20 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Feb 2023 – 16 Feb 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Jun 2021 – 9 Jul 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Feb 2020 – 25 Feb 2020 | Medical Devices & Rad Health | WL | View 483 → |
| 2 Nov 2016 – 8 Nov 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Sep 2013 – 30 Sep 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Feb 2010 | Not recorded | 483 | On file |
| 21 Mar 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
20 May 2026
ISO 13485:2016 Clause 7.3.9
Records of design and development changes and their reviews not maintained
Cited by Javonica F Penn
20 May 2026
ISO 13485:2016 Clause 7.3.9
Records of design and development changes and their reviews not maintained
Cited by Javonica F Penn
20 May 2026
ISO 13485:2016 Clause 7.4.1
Records of supplier (re)evaluation, selection, and monitoring not maintained
Cited by Javonica F Penn
20 May 2026
ISO 13485:2016 Clause 7.4.1
Records of supplier (re)evaluation, selection, and monitoring not maintained
Cited by Javonica F Penn
20 May 2026
ISO 13485:2016 Clause 7.5.6
Procedures for validation of processes not documented
Cited by Javonica F Penn
Investigators
FDA investigators tied to this site in the record.
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 | 5x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.3.9 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.5.6 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.3.4 | Cited across public-safe Form 483 observations | 2x |
| 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 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Klarity Medical Products LLC's 8 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