Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-12.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Mar 2026 – 12 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Oct 2023 – 19 Oct 2023 | Medical Devices & Rad Health | Clean | |
| 13 Mar 2017 – 17 Mar 2017 | Medical Devices & Rad Health | 483 | On file |
| 4 Aug 2014 – 7 Aug 2014 | Medical Devices & Rad Health | 483 | On file |
| 8 Jul 2013 – 18 Jul 2013 | Medical Devices & Rad Health | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Mar 2026
ISO 13485:2016 Clause 4.1.4
Changes to the QMS not adequately controlled or evaluated
Cited by Jude C Dike
12 Mar 2026
ISO 13485:2016 Clause 8.3.1
Records of nonconforming product and actions taken not maintained
Cited by Jude C Dike
Investigators
FDA investigators tied to this site in the record.
Jude C Dike1 insp.
Maryam Tabatabaie1 insp.
Felix J Marrero1 insp.
Sarah A Hassas1 insp.
Francis J Eng1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.4 | 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 Fudakang Industrial Co Ltd's 4 Form 483s
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