FDA Inspection
WORLD SOURCE SIMPLE LLCWORLD SOURCE SIMPLE LLC – FDA Inspection, Mar 10, 2026
Record Details
This FDA Inspection record concerns WORLD SOURCE SIMPLE LLC, with an inspection on March 10, 2026, issued by the Cincinnati District Office, covering medical devices & rad health.
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ID · fc14fd35-3833-4cf9-8790-880a639073e5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1307158
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
5- 21 CFR 803.17Lack of Written MDR Procedures
- ISO 13485:2016 Clause 4.1.1QMS not documented and maintained adequately
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 5.1Lack of evidence for top management's commitment to QMS
- ISO 13485:2016 Clause 6.2Personnel competency not adequate
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Other FDA inspections of WORLD SOURCE SIMPLE LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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