Overview
- 8 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
MPMarine Polymer TechnologiesTopsfield, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 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 483 report
Get the verbatim text of all 8 observations
The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere