Overview
- 8 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-15.
At a glance
Inspections
8
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Apr 2026 – 15 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 31 Aug 2023 – 29 Sep 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 May 2022 – 1 Jul 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Feb 2020 – 11 Mar 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 31 Oct 2017 – 17 Nov 2017 | Medical Devices & Rad Health | WL | View 483 → |
| 20 Dec 2012 | Not recorded | 483 | View 483 → |
| 27 Jul 2009 | Not recorded | 483 | On file |
| 20 Apr 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 May 2026
ISO 13485:2016 Clause 7.5.1
Medical device or batch records not adequate
Cited by Frank J Marciniak
15 May 2026
ISO 13485:2016 Clause 7.5.1
Medical device or batch records not adequate
Cited by Frank J Marciniak
15 May 2026
ISO 13485:2016 Clause 7.6
Equipment calibration or verification not performed
Cited by Frank J Marciniak
Investigators
FDA investigators tied to this site in the record.
Frank J Marciniak4 insp.
Gobiga Vanniyasingam1 insp.
Amy M Cramer1 insp.
Kelli F Dobilas1 insp.
James E Frye1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 10x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 4.2.4 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.5.1 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.6 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.2.4 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.3.1 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.3.3 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.4 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.5.3 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.200(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | 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) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.86 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Light Age, Inc.'s 7 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