FDA Inspection 1309448 — Consolidated Research, Inc.
The FDA completed an inspection of Consolidated Research, Inc. on March 25, 2026 in Euclid, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 25, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Euclid, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22801 | 21 CFR 830.310(b) | GUDID Information required for unique device identification. |
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23032 | ISO 13485:2016 Clause 4.2.1 | Quality management system documentation not adequate |
| 23088 | ISO 13485:2016 Clause 7.1 | Records of risk management activities in product realization not maintained |
| 23145 | ISO 13485:2016 Clause 7.4.1 | Records of supplier (re)evaluation, selection, and monitoring not maintained |
| 23248 | ISO 13485:2016 Clause 8.3.4 | Rework records not maintained |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |