# FDA 483 - BBS Enterprises, DBA Complexus Medical - February 04, 2026

Source: https://www.globalkeysolutions.net/records/483/bbs-enterprises-dba-complexus-medical/b130bd5b-8e09-4ad2-8e4a-1a49aaa83ddd

> FDA 483 for BBS Enterprises, DBA Complexus Medical on February 04, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BBS Enterprises, DBA Complexus Medical
- Inspection Date: 2026-02-04
- Product Type: device
- Office Name: Detroit District Office
- Summary: An FDA inspection of BBS Enterprises in Mishawaka, IN, from February 2-4, 2026, revealed significant deficiencies in their quality management system. Observations included a lack of validation for production processes, inadequate documentation of product requirements for intended use, and a failure to apply a risk-based approach to corrective actions and overall risk management in product realization. These issues indicate systemic problems in ensuring product quality and safety.

## Related Documents

- [483 - 2023-04-12](https://www.globalkeysolutions.net/records/483/bbs-enterprises-dba-complexus-medical/175c8b2e-67e8-4c74-85fb-ab63a99301cc)

## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.globalkeysolutions.net/companies/bbs-enterprises-dba-complexus-medical/81108c73-1c94-4b9c-a7c2-b48ae35c960d

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03