Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-05.
At a glance
Inspections
3
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Feb 2026 – 5 Feb 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Apr 2023 – 20 Apr 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Jun 2019 – 26 Jun 2019 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Feb 2026
ISO 13485:2016 Clause 8.5.2
Corrective action procedures not documented
Cited by Alex J Wild
Investigators
FDA investigators tied to this site in the record.
Alex J Wild2 insp.
Richard K Vogel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.3.4 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Ecotec Manufacturing, Inc.'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