# FDA 483 - Sol-Millennium Medical Inc. - May 08, 2025

Source: https://www.globalkeysolutions.net/records/483/sol-millennium-medical-inc/64e6b3ff-6be1-425f-89a8-914b15d388bd

> FDA 483 for Sol-Millennium Medical Inc. on May 08, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sol-Millennium Medical Inc.
- Inspection Date: 2025-05-08
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Sol-Millennium Medical Inc. in Chicago, IL, revealed significant deficiencies in their medical device reporting (MDR) and corrective and preventive action (CAPA) systems. The firm failed to submit complete initial MDRs and timely supplemental MDRs, and their CAPA procedures were inadequate, failing to address root causes or previous violations. These issues indicate a systemic lack of compliance in handling complaints and ensuring product quality for medication delivery devices.

## Related Documents

- [483 - 2023-12-20](https://www.globalkeysolutions.net/records/483/sol-millennium-medical-inc/3c802d86-132f-45e8-8842-7483a79b7c6e)

## Related Officers

- [Chad E. Schmear](https://www.globalkeysolutions.net/people/chad-e-schmear/275a4c57-d288-46f9-8257-64fcd96159ce)
- [Medical Device Specialist](https://www.globalkeysolutions.net/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.globalkeysolutions.net/companies/sol-millennium-medical-inc/b16b2cdf-7320-431d-acc7-84e8090fa4ca

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669