FDA Inspection 1318408 — Dana Molded Products Inc.
The FDA completed an inspection of Dana Molded Products Inc. on May 22, 2026 in Carpentersville, IL. 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
- May 22, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Carpentersville, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23023 | ISO 13485:2016 Clause 4.1.4 | Changes to the QMS not adequately controlled or evaluated |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23127 | ISO 13485:2016 Clause 7.3.8 | Design and development transfer procedures not documented |
| 23169 | ISO 13485:2016 Clause 7.5.6 | Procedures for validation of processes not documented |