FDA Inspection
Surgical Design IncSurgical Design Inc – FDA Inspection, Aug 19, 2026
Record Details
This FDA Inspection record concerns Surgical Design Inc, with an inspection on August 19, 2026, issued by the Baltimore District Office, covering medical devices & rad health.
- Person
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ID · 34221002-c75f-44e0-ab1a-acc361a83841
Inspection Facts
- Inspection number
- 1331796
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.17(b)(4)Info which facilitates timely FDA follow-up
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
- ISO 13485:2016 Clause 8.1Monitoring, measurement, analysis, and improvement processes not adequate
- ISO 13485:2016 Clause 8.2.1Information gathered in feedback process not used as input into risk management
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
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Other FDA inspections of Surgical Design Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 17, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 18, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Surgical Design Inc
- FDA Inspection 883886 - 2014-06-17
- FDA Inspection 835866 - 2013-06-18
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