FDA Inspection 1325532 — Marine Polymer Technologies
The FDA completed an inspection of Marine Polymer Technologies on July 6, 2026 in Topsfield, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 6, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Topsfield, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23023 | ISO 13485:2016 Clause 4.1.4 | Changes to the QMS not adequately controlled or evaluated |
| 23075 | ISO 13485:2016 Clause 6.2(e) | Records of personnel competence not maintained |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |
| 23237 | ISO 13485:2016 Clause 8.3.1 | Procedure for nonconforming product not documented |