Overview
- 12 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-28.
At a glance
Inspections
12
Form 483s
3
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Mar 2025 – 28 Mar 2025 | Human Drugs | Clean | |
| 1 Nov 2023 – 8 Nov 2023 | Animal Drugs & Feeds | Clean | |
| 1 May 2019 – 3 May 2019 | Human Drugs | 483 | View 483 → |
| 25 Jul 2018 – 1 Aug 2018 | Human Drugs | Clean | |
| 23 Mar 2016 – 25 Mar 2016 | Animal Drugs & Feeds | 483 | View 483 → |
| 26 Aug 2013 – 29 Aug 2013 | Human Drugs | Clean | |
| 1 Dec 2010 | Not recorded | Clean | |
| 11 Jun 2010 | Not recorded | Clean | |
| 15 Jun 2009 | Not recorded | 483 | On file |
| 3 Sep 2008 | Not recorded | Clean | |
| 24 Sep 2004 | Not recorded | Clean | |
| 26 Jul 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Mar 2016
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Amanda L Fyles, Darren S Brown, Kathy Kuo
Investigators
FDA investigators tied to this site in the record.
Tiara M Brown2 insp.
Uttaniti Limchumroon2 insp.
Lillian S Wu1 insp.
Liming Zhang1 insp.
Stephanie A Slater1 insp.
Amanda L Fyles1 insp.
Darren S Brown1 insp.
Kathy Kuo1 insp.
Andy B Lee1 insp.
Joey V Quitania1 insp.
Lakecha N Lewis1 insp.
Binh T Nguyen1 insp.
Kim L Thomas Cruse1 insp.
John A Gonzalez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Element Materials Technology Pharma US LLC's 3 Form 483s
Source PDFs, 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