Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2013-05-23.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 May 2013 – 23 May 2013 | Medical Devices & Rad Health | 483 | On file |
| 23 Nov 2010 | Not recorded | Clean | |
| 4 Feb 2009 | Not recorded | 483 | On file |
| 18 Nov 2008 | Not recorded | Clean | |
| 11 Sep 2008 | Not recorded | 483 | On file |
| 14 Jan 2003 | Not recorded | Clean | |
| 19 Nov 2001 | Not recorded | Clean | |
| 10 Feb 2000 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Miaja Umaedi1 insp.
Abraham M Maekele1 insp.
Trang N Cox1 insp.
Leo J Lagrotte1 insp.
Yvette M Lacour-Davis1 insp.
Laverne Kimble1 insp.
Kham Phommachanh1 insp.
Selene T Torres1 insp.
Francis J Eng1 insp.
Full site report
Get the verbatim findings behind Cardiogenesis Corporation's 3 Form 483s
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