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1208208

Clinical Laboratories of Hawaii, LLP — FEI 2972911

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 15, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Honolulu, HI (United States)

Facility

Other inspections at this facility

  • 1280587 (NAI Thu Aug 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1279652 (NAI Tue Aug 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1055322 (NAI Thu May 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053641 (VAI Wed May 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1051026 (NAI Wed Apr 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
15421 CFR 606.160(a)(1)Concurrent documentation
1803921 CFR 606.100(b)(22)Control risk of bacterial contamination of platelets
1805121 CFR 606.145(c)Tx service release of product, notification, ID