# FDA 483 - BBS Enterprises, DBA Complexus Medical - April 12, 2023

Source: https://www.globalkeysolutions.net/records/483/bbs-enterprises-dba-complexus-medical/175c8b2e-67e8-4c74-85fb-ab63a99301cc

> FDA 483 for BBS Enterprises, DBA Complexus Medical on April 12, 2023. 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: 2023-04-12
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: BBS Enterprises, DBA Complexus Medical, a medical device manufacturer in Mishawaka, IN, was cited with two observations during an FDA inspection. The firm failed to adequately establish procedures for receiving and investigating customer complaints, as evidenced by incomplete feedback forms. Additionally, process control procedures were found to be inadequate, with manufacturing operations using process parameter settings that were outside validated ranges without objective evidence of validation.

## Related Documents

- [483 - 2026-02-04](https://www.globalkeysolutions.net/records/483/bbs-enterprises-dba-complexus-medical/b130bd5b-8e09-4ad2-8e4a-1a49aaa83ddd)

## 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/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0