Overview
- 6 FDA inspections are on record.
- 0 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-21.
At a glance
Inspections
6
Form 483s
0
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Mar 2024 – 21 Mar 2024 | Biologics | Clean | |
| 20 Apr 2022 – 21 Apr 2022 | Biologics | Clean | |
| 19 Jul 2021 – 27 Jul 2021 | Medical Devices & Rad Health | Clean | |
| 6 Dec 2018 – 7 Dec 2018 | Biologics | Clean | |
| 21 Apr 2016 | Biologics | Clean | |
| 21 Mar 2012 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Full site report
Get the verbatim findings behind K2M, Inc.'s inspection record
The full inspection record, as Atlas holds it, 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