# FDA 483 - WORLD SOURCE SIMPLE LLC - October 24, 2022

Source: https://www.keypedia.com/records/483/world-source-simple-llc/c46ee88d-d846-4841-963e-1a84a2d58647

> FDA 483 for WORLD SOURCE SIMPLE LLC on October 24, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WORLD SOURCE SIMPLE LLC
- Inspection Date: 2022-10-24
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: WORLD SOURCE SIMPLE LLC, an initial distributor of medical devices in Lima, OH, was cited with two observations during an FDA inspection. The firm failed to establish procedures for handling customer complaints and for Medical Device Reporting (MDR). These deficiencies indicate a lack of essential quality system controls for medical device distribution.

## 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