FDA Inspection
Orion Medical Solutions, LLCOrion Medical Solutions, LLC – FDA Inspection, May 21, 2026
Record Details
This FDA Inspection record concerns Orion Medical Solutions, LLC, with an inspection on May 21, 2026, issued by the Atlanta District Office, covering medical devices & rad health.
- Company
- Orion Medical Solutions, LLC
- Inspection Date
- May 21, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 76bcc622-609e-419b-b624-e73149e4fc68
Inspection Facts
- Inspection number
- 1318170
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- ISO 13485:2016 Clause 4.1.5External party controls do not include written quality agreements
- ISO 13485:2016 Clause 4.2.4Lack of document control
- ISO 13485:2016 Clause 7.4.2Purchasing information lacks written agreement regarding notification of changes
- ISO 13485:2016 Clause 7.5.9.1Procedures for traceability were not documented
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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