Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-11.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Jun 2024 – 11 Jun 2024 | Foods & Cosmetics | 483 | View 483 → |
| 23 Sep 2021 – 30 Sep 2021 | Foods & Cosmetics | 483 | View 483 → |
| 29 Mar 2017 – 6 Apr 2017 | Foods & Cosmetics | 483 | View 483 → |
| 5 Jan 2016 – 19 Jan 2016 | Foods & Cosmetics | 483 | View 483 → |
| 14 Sep 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Sep 2021
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Khunnathee Stoner
6 Apr 2017
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Dana M Lewis
6 Apr 2017
21 CFR 111.75(c)(2)
Specifications met - test, examinations; compliance
Cited by Dana M Lewis
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.75(c)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.127(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.410(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.87 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Trace Elements, Inc's 4 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