FDA Inspection 1317884 — Currie Medical Inc.
The FDA completed an inspection of Currie Medical Inc. on May 15, 2026 in Norfolk, VA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 15, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Norfolk, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23024 | ISO 13485:2016 Clause 4.1.5 | Inadequate monitoring and control over outsourced processes |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23169 | ISO 13485:2016 Clause 7.5.6 | Procedures for validation of processes not documented |
| 23172 | ISO 13485:2016 Clause 7.5.6 | Computer software used in production and service provision not validated |
| 23193 | ISO 13485:2016 Clause 7.6 | Procedures for monitoring and measuring equipment requirements not documented |