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1088192

Pinnacle Biologics Inc — FEI 3010119152

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 30, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Bannockburn, IL (United States)

Facility

Other inspections at this facility

  • 1272551 (NAI Fri Jun 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1172994 (VAI Mon Jun 27 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 958308 (VAI Tue Mar 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 866408 (VAI Tue Feb 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
317321 CFR 820.198(d)Evaluation, timeliness, identification
63021 CFR 803.17Lack of Written MDR Procedures
73221 CFR 803.50(a)(2)Individual Report of Malfunction