Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-02-12.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Feb 2020 – 12 Feb 2020 | Human Drugs | Clean | |
| 4 Dec 2017 – 8 Dec 2017 | Human Drugs | Clean | |
| 30 May 2016 – 3 Jun 2016 | Human Drugs | 483 | On file |
| 9 Dec 2013 – 13 Dec 2013 | Human Drugs | Clean | |
| 29 Sep 2010 | Not recorded | 483 | On file |
| 12 Oct 2006 | Not recorded | Clean | |
| 13 Jun 2001 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
MRA DavisM1 insp.
Anastasia M Shields1 insp.
Jose E Melendez1 insp.
Monica M Mcclure1 insp.
Kristy A Zielny1 insp.
Full site report
Get the verbatim findings behind Fermion OY's 2 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