Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-07.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Jun 2024 – 7 Jun 2024 | Foods & Cosmetics | 483 | On file |
| 30 Aug 2021 – 3 Sep 2021 | Foods & Cosmetics | 483 | On file |
| 10 Sep 2018 – 11 Sep 2018 | Foods & Cosmetics | Clean | |
| 24 Oct 2016 – 26 Oct 2016 | Foods & Cosmetics | Clean | |
| 9 Jan 2014 – 14 Jan 2014 | Foods & Cosmetics | 483 | On file |
| 12 Jul 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Jun 2024
21 CFR 111.123(a)(1)
Quality control operations - master manufacturing record, modifications
Cited by Alan Escalona
7 Jun 2024
21 CFR 111.205(a)
Master manufacturing record - each batch
Cited by Alan Escalona
7 Jun 2024
21 CFR 111.95(b)(2)
Documentation - supplier qualification
Cited by Alan Escalona
3 Sep 2021
21 CFR 111.120(e)
Quality control operations - quarantine
Cited by Sheila Alaghemand, Gary C Pecic, Siobhan G Taylor
3 Sep 2021
21 CFR 111.120(e)
Quality control operations - quarantine
Cited by Sheila Alaghemand, Gary C Pecic, Siobhan G Taylor
Investigators
FDA investigators tied to this site in the record.
Alan Escalona1 insp.
Sheila Alaghemand1 insp.
Gary C Pecic1 insp.
Siobhan G Taylor1 insp.
David A Gonzalez1 insp.
Roger J Adams1 insp.
Christine L Williams1 insp.
Larisa E Pavlick1 insp.
Jennifer R Mathern1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.123(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.120(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.25 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.365(h) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.560(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.95(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Trace Herbals 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