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1261222

Accupac, Llc — FEI 3010166945

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 13, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Lakewood, NJ (United States)

Facility

Other inspections at this facility

  • 1240333 (VAI Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1156637 (NAI Thu Nov 18 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1083332 (NAI Tue Mar 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1009775 (VAI Tue Feb 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
2280121 CFR 830.310(b)GUDID Information required for unique device identification.
23019ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
23142ISO 13485:2016 Clause 7.4.1Supplier performance not monitored
23167ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated