Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-06.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Mar 2026 – 6 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Sep 2023 – 25 Sep 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Aug 2019 – 5 Sep 2019 | Medical Devices & Rad Health | 483 | On file |
| 10 Apr 2018 – 18 Apr 2018 | Medical Devices & Rad Health | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Mar 2026
ISO 13485:2016 Clause 7.5.6
Procedures for validation of processes lack required elements
Cited by Edward E Lockwood
6 Mar 2026
ISO 13485:2016 Clause 7.6
Equipment calibration or verification not performed
Cited by Edward E Lockwood
6 Mar 2026
ISO 13485:2016 Clause 8.2.2
Lack of documented justification for not investigating complaint(s)
Cited by Edward E Lockwood
Investigators
FDA investigators tied to this site in the record.
Edward E Lockwood4 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 801.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.3.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ortho Solutions LC's 4 Form 483s
Source PDFs 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