Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-07-06.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Jun 2026 – 6 Jul 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Jul 2021 – 19 Jul 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Feb 2017 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Jul 2026
ISO 13485:2016 Clause 4.1.4
Changes to the QMS not adequately controlled or evaluated
Cited by Thomas Siebertz
6 Jul 2026
ISO 13485:2016 Clause 4.1.4
Changes to the QMS not adequately controlled or evaluated
Cited by Thomas Siebertz
6 Jul 2026
ISO 13485:2016 Clause 6.2(e)
Records of personnel competence not maintained
Cited by Thomas Siebertz
6 Jul 2026
ISO 13485:2016 Clause 6.2(e)
Records of personnel competence not maintained
Cited by Thomas Siebertz
6 Jul 2026
ISO 13485:2016 Clause 8.2.2
Complaint handling procedures not documented
Cited by Thomas Siebertz
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 820.30(a) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 4.1.4 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 6.2(e) | 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 8.3.1 | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Marine Polymer Technologies' 2 Form 483s
Source PDFs 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