Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-27.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Mar 2026 – 27 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Aug 2023 – 25 Aug 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Feb 2018 | Medical Devices & Rad Health | Clean | |
| 15 Jul 2014 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Mar 2026
ISO 13485:2016 Clause 8.2.2
Complaint handling procedures not documented
Cited by Jonathan Ho
27 Mar 2026
ISO 13485:2016 Clause 8.5.2
Corrective action procedures not documented
Cited by Jonathan Ho
25 Aug 2023
21 CFR 820.50(a)
Evaluation of suppliers, contractors, etc., requirements
Cited by Monica L Gutierrez
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 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Virak Orthopedics LLC's 2 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