FDA Inspection
Surgical Direct, Inc.Surgical Direct, Inc. – FDA Inspection, Aug 3, 2018
Record Details
This FDA Inspection record concerns Surgical Direct, Inc., with an inspection on August 3, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ce4eecdd-df5c-4036-9768-8ae892f81ba7
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1061444
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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Other FDA inspections of Surgical Direct, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2026 | VAI | Florida District Office | Compliance: Medical Devices |
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