Overview
- 9 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-09-14.
At a glance
Inspections
9
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Sep 2018 – 14 Sep 2018 | Biologics | 483 | On file |
| 22 May 2017 – 25 May 2017 | Medical Devices & Rad Health | Clean | |
| 12 May 2016 – 20 May 2016 | Biologics | 483 | On file |
| 15 Sep 2014 – 22 Sep 2014 | Biologics | 483 | On file |
| 27 Apr 2012 | Not recorded | 483 | On file |
| 25 Feb 2011 | Not recorded | 483 | On file |
| 19 Jan 2010 | Not recorded | 483 | On file |
| 13 Oct 2008 | Not recorded | 483 | On file |
| 9 Nov 2005 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Jacqueline M Diaz Albert2 insp.
Mihaly S Ligmond2 insp.
Michele L Forster1 insp.
Sarah M Forney1 insp.
Teresita C Mercado1 insp.
Prabhu P Raju1 insp.
Susan S Yu1 insp.
Helen B Ricalde1 insp.
Omotunde O Osunsanmi1 insp.
Full site report
Get the verbatim findings behind this site's 7 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