Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-16.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Aug 2024 – 16 Aug 2024 | Biologics | Clean | |
| 2 Apr 2019 – 5 Apr 2019 | Biologics | 483 | On file |
| 25 Jan 2016 – 29 Jan 2016 | Biologics | 483 | On file |
| 20 Jan 2014 – 28 Jan 2014 | Biologics | 483 | On file |
| 11 Nov 2011 | Not recorded | 483 | On file |
| 17 Sep 2009 | Not recorded | 483 | On file |
| 20 Jun 2007 | Not recorded | Clean | |
| 19 Mar 2004 | Not recorded | Clean | |
| 20 Sep 2002 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Susan M Jackson1 insp.
Thai D Truong1 insp.
Debra M Emerson1 insp.
Michele L Forster1 insp.
Mihaly S Ligmond1 insp.
Cynthia Jim1 insp.
Burnell M Henry1 insp.
Prabhu P Raju1 insp.
Jacqueline M Diaz Albert1 insp.
Full site report
Get the verbatim findings behind SmartPractice Denmark ApS' 5 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