Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-25.
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 |
|---|---|---|---|
| 22 Jul 2024 – 25 Jul 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Dec 2023 – 21 Dec 2023 | Medical Devices & Rad Health | 483 | On file |
| 24 Aug 2015 – 27 Aug 2015 | Medical Devices & Rad Health | WL | View 483 → |
| 24 Sep 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jul 2024
21 CFR 803.17(a)(3)
Lack of System for Timely Submission of Reports
Cited by Melissa A Zuppe
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 | 3x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.180 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Implants International Ltd.'s 3 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