FDA Inspection 1310194 — Surgical Direct, Inc.
The FDA completed an inspection of Surgical Direct, Inc. on March 24, 2026 in Orange City, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 24, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Orange City, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23030 | ISO 13485:2016 Clause 4.1.6 | Records of QMS software validation not maintained |
| 23060 | ISO 13485:2016 Clause 5.6.1 | Management review procedures not documented |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23164 | ISO 13485:2016 Clause 7.5.4 | Records of servicing activities not maintained |
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |