FDA Inspection
BBS Enterprises, DBA Complexus MedicalBBS Enterprises, DBA Complexus Medical – FDA Inspection, Feb 4, 2026
Record Details
This FDA Inspection record concerns BBS Enterprises, DBA Complexus Medical, with an inspection on February 4, 2026, issued by the Detroit District Office, covering medical devices & rad health.
- Inspection Date
- February 4, 2026
- Product Type
- Medical Devices & Rad Health
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ID · 7fb0d9e4-0b85-4899-a8b9-a2bceb3cfb28
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1302466
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
4- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.2.1Requirements related to product not determined
Full citation text and observation details available on the Dashboard.
Other FDA inspections of BBS Enterprises, DBA Complexus Medical
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 18, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for BBS Enterprises, DBA Complexus Medical
- FDA Inspection 1203308 - 2023-04-12
- FDA Inspection 1105192 - 2019-09-18
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