Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-22.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 May 2026 – 22 May 2026 | Foods & Cosmetics | 483 | View 483 → |
| 1 Aug 2018 – 27 Aug 2018 | Foods & Cosmetics | 483 | View 483 → |
| 27 Mar 2017 – 25 Apr 2017 | Foods & Cosmetics | 483 | View 483 → |
| 21 Mar 2016 – 20 Apr 2016 | Foods & Cosmetics | WL | View 483 → |
| 26 Aug 2013 – 3 Sep 2013 | Foods & Cosmetics | 483 | View 483 → |
| 14 Jul 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Aug 2018
21 CFR 111.105(i)
QC - required operations master manufacturing/batch records
Cited by Elodie X Tong-Lin
27 Aug 2018
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Elodie X Tong-Lin
Investigators
FDA investigators tied to this site in the record.
Elodie X Tong-Lin3 insp.
Edna J Hidalgo2 insp.
Jeffrey J Leclair1 insp.
Kacie M Crowther1 insp.
Jennifer L Johnson1 insp.
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 111.70(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.105(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(k) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.303 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.475(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.77(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Threshold Enterprises, Ltd.'s 5 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