FDA Inspection
Surgical Direct, Inc.Surgical Direct, Inc. – FDA Inspection, Mar 24, 2026
Record Details
This FDA Inspection record concerns Surgical Direct, Inc., with an inspection on March 24, 2026, issued by the Florida District Office, covering medical devices & rad health.
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ID · da80e5df-3e20-4abf-b4e1-a7b270c03e71
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1310194
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
6- ISO 13485:2016 Clause 7.5.4Records of servicing activities not maintained
- ISO 13485:2016 Clause 8.2.4Complaint handling records not maintained
- ISO 13485:2016 Clause 5.6.1Management review procedures not documented
- ISO 13485:2016 Clause 4.1.6Records of QMS software validation not maintained
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Surgical Direct, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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