# WORLD SOURCE SIMPLE LLC – FDA 483, Mar 10, 2026

Source: https://www.keypedia.com/records/483/world-source-simple-llc/bf93ec02-36e3-4c42-b44a-78824a93bd20

> FDA 483 for WORLD SOURCE SIMPLE LLC on March 10, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WORLD SOURCE SIMPLE LLC
- Inspection Date: 2026-03-10
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: WORLD SOURCE SIMPLE LLC, an initial importer and distributor of Class I and Class II medical devices in Lima, OH, was cited for significant deficiencies in its quality management system. The inspection revealed a complete absence of a documented quality system, including a quality policy, objectives, and procedures for complaint handling and Medical Device Reporting. Additionally, personnel lacked documented training and experience for quality operations.

## Related Documents

- [483 - 2022-10-24](https://www.keypedia.com/records/483/world-source-simple-llc/c46ee88d-d846-4841-963e-1a84a2d58647) — date: October 24, 2022

## Related Officers

- [investigator](https://www.keypedia.com/people/javonica-f-penn/56294265-08fc-4d1d-8a34-626fc4dad457)

Company: https://www.keypedia.com/companies/world-source-simple-llc/1b16766b-fc47-4f63-bc4f-b5bd08c98304

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22