1274181

Pointcore Supply Chain Service LLC — FEI 3024510438

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 26, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Peoria, IL (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
229321 CFR 820.20(d)Quality plan
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
366521 CFR 820.20(b)(3)Management representative
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures
367121 CFR 820.25(a)Personnel
405721 CFR 820.20(a)Management ensuring quality policy is understood