FDA Inspection
RSI Technology Group, LLCRSI Technology Group, LLC – FDA Inspection, Apr 17, 2026
Record Details
This FDA Inspection record concerns RSI Technology Group, LLC, with an inspection on April 17, 2026, issued by the Dallas District Office, covering medical devices & rad health.
- Company
- RSI Technology Group, LLC
- Inspection Date
- April 17, 2026
- Product Type
- Medical Devices & Rad Health
- Office
- Dallas District Office
- Person
View Company Profile
ID · 28406662-f7fb-46a8-97e9-52f0f87acd3a
Inspection Facts
- Inspection number
- 1313466
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.3.2Design and development of product not planned and controlled
- ISO 13485:2016 Clause 7.4.2Purchasing information does not include all required elements
- ISO 13485:2016 Clause 7.5.1Production controls not adequate
- ISO 13485:2016 Clause 7.5.7Processes for sterilization and sterile barrier systems not validated
- ISO 13485:2016 Clause 8.1Monitoring, measurement, analysis, and improvement processes not adequate
- ISO 13485:2016 Clause 8.3.1Nonconforming product not adequately evaluated
- ISO 13485:2016 Clause 8.5.1Changes to maintain QMS and device not identified and implemented
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Other FDA inspections of RSI Technology Group, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 22, 2023 | Not classified | Dallas District Office |
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