FDA Inspection 1304430 — Rogers Foam Corporation
The FDA completed an inspection of Rogers Foam Corporation on February 25, 2026 in Mount Sterling, KY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 25, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mount Sterling, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |
| 23170 | ISO 13485:2016 Clause 7.5.6 | Procedures for validation of processes lack required elements |