Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-07.
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 |
|---|---|---|---|
| 4 May 2026 – 7 May 2026 | Foods & Cosmetics | 483 | View 483 → |
| 8 Sep 2023 – 22 Sep 2023 | Foods & Cosmetics | 483 | View 483 → |
| 4 Nov 2019 – 7 Nov 2019 | Foods & Cosmetics | 483 | View 483 → |
| 28 Oct 2016 – 31 Oct 2016 | Foods & Cosmetics | Clean | |
| 30 Jan 2014 – 6 Feb 2014 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
7 May 2026
21 CFR 117.135(c)(1)
Process preventive controls - Appropriate (Adequate)
Cited by Katherine Vargas-Serrano
7 May 2026
21 CFR 117.40
Equipment and utensils - Design and maintenance
Cited by Katherine Vargas-Serrano
22 Sep 2023
21 CFR 117.135(a)(1)
Process preventive controls - Identify (Written)
Cited by Jorge L Lajara
22 Sep 2023
21 CFR 117.135(c)(3)
Sanitation preventive controls - Appropriate (Adequate)
Cited by Jorge L Lajara
Investigators
FDA investigators tied to this site in the record.
Katherine Vargas-Serrano1 insp.
Jorge L Lajara1 insp.
Rafael Gonzalez1 insp.
Ivonne A Vicente1 insp.
Miguel G Manzano1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 110.20(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.410(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ELM, 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