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ICU MEDICAL, INC. — FDA Facility Profile

FEI 2025816

ICU MEDICAL, INC. is an FDA-registered facility (FEI 2025816) located in SAN CLEMENTE, CA, US. RegDataLab tracks 2 FDA inspections at this facility.

Facility Details

Location
SAN CLEMENTE, CA (US)
Registration Expires
N/A
Operations
Source
device

Recent inspections

  • 1021502 (NAI Fri Jul 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 819159 (NAI Wed Feb 13 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • EI5-5506310-3/11/1 (Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EI5-5506310-3/21/1 (Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EI5-5506310-3/21/2 (Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EI5-5506310-3/31/1 (Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-7330704-7/11/1 (Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-7330668-4/11/1 (Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources