Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-19.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Mar 2026 – 19 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Jul 2018 – 18 Jul 2018 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Mar 2026
ISO 13485:2016 Clause 4.1.4
Changes to the QMS not adequately controlled or evaluated
Cited by Suyang Qin, Shawn Choi
19 Mar 2026
ISO 13485:2016 Clause 6.4.1
Work environment requirements and procedures not documented
Cited by Suyang Qin, Shawn Choi
19 Mar 2026
ISO 13485:2016 Clause 7.4.2
Purchasing information does not include all required elements
Cited by Suyang Qin, Shawn Choi
19 Mar 2026
ISO 13485:2016 Clause 7.5.1
Production controls not adequate
Cited by Suyang Qin, Shawn Choi
19 Mar 2026
ISO 13485:2016 Clause 7.5.6
Procedures for validation of processes lack required elements
Cited by Suyang Qin, Shawn Choi
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 | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 4.1.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.4.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.1 | 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 8.5.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Nanovis LLC's 2 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