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1302466

BBS Enterprises — FEI 3009887475

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 4, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Mishawaka, IN (United States)

Facility

Other inspections at this facility

  • 1203308 (NAI Wed Apr 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1105192 (NAI Wed Sep 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
23019ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
23087ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
23091ISO 13485:2016 Clause 7.2.1Requirements related to product not determined
23167ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated