Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-26.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Mar 2026 – 26 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Jul 2021 | Medical Devices & Rad Health | Clean | |
| 1 Nov 2016 – 9 Nov 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 Dec 2013 – 9 Dec 2013 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Mar 2026
ISO 13485:2016 Clause 5.6.1
Management review procedures not documented
Cited by Sarah A Hassas
26 Mar 2026
ISO 13485:2016 Clause 5.6.1
Management review procedures not documented
Cited by Sarah A Hassas
26 Mar 2026
ISO 13485:2016 Clause 7.3.5
Records of design and development reviews not maintained
Cited by Sarah A Hassas
26 Mar 2026
ISO 13485:2016 Clause 7.3.5
Records of design and development reviews not maintained
Cited by Sarah A Hassas
26 Mar 2026
ISO 13485:2016 Clause 7.4.1
Procedures for purchasing process not documented
Cited by Sarah A Hassas
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 820.80(d) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 5.6.1 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.3.5 | 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 8.3.1 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 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 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hanuri Distribution Inc's 3 Form 483s
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