Overview
- 19 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-10-17.
At a glance
Inspections
19
Form 483s
9
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Sep 2018 – 17 Oct 2018 | Human Drugs | 483 | View 483 → |
| 15 Dec 2015 – 18 Dec 2015 | Human Drugs | Clean | |
| 8 Dec 2015 – 18 Dec 2015 | Human Drugs | Clean | |
| 24 Mar 2015 – 2 Apr 2015 | Human Drugs | Clean | |
| 12 Aug 2014 – 15 Aug 2014 | Human Drugs | Clean | |
| 15 Apr 2014 – 25 Apr 2014 | Human Drugs | Clean | |
| 12 Dec 2013 – 20 Dec 2013 | Human Drugs | Clean | |
| 9 Dec 2013 – 12 Dec 2013 | Human Drugs | 483 | On file |
| 4 Dec 2013 – 9 Dec 2013 | Human Drugs | 483 | On file |
| 25 Jun 2013 – 2 Jul 2013 | Human Drugs | Clean | |
| 29 Oct 2012 | Not recorded | 483 | On file |
| 2 Nov 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Joel Martinez10 insp.
Johann M Fitch3 insp.
Camille D Brown2 insp.
Robert T Lorenz2 insp.
Leighton K Ngai2 insp.
Janete F Guardia1 insp.
Rene R Ramirez1 insp.
Tricia S Martinez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.60 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Worldwide Clinical Trials Early Phase Services' 9 Form 483s
Verbatim observations and recurring CFR citations, 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