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 VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 25, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: 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 |