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ICU Medical Inc.

www.icumed.com

Latest From ICU Medical Inc.

FDA Warns Lymol To Assess Talc Lead Risk Per ICH Q3D; Puts Others On Notice

A warning letter to firm with legacy talc drug product puts pharmaceutical industry on notice: the US FDA expects applicants to meet requirements agency imposes post-approval for matters like elemental impurities compliance.

Enforcement Quality

As Saline Shortages Persist, Providers Pin Hopes On Feds Demanding Backup Manufacturing Capacity

As market forces, seasonal flu and extreme weather cause US shortages of intravenous saline solutions to persist, providers writing in NEJM are heartened by idea that federal Homeland Security Department could step in to require manufacturing redundancies. Will industry solve the problem before it becomes a matter of national security?

Manufacturing Compliance

'Qui Tam' Suit Says Hospira Billed Government For Faulty Infusion Pumps

A newly unsealed whistleblower suit filed in Illinois federal court in 2016 alleges the company failed to alert US FDA or customers to software and power cable issues that could have harmed patients and users. Pfizer, which purchased Hospira in 2015 and sold the infusion pump unit in 2017, says the case has no merit, and the government has declined to intervene.

Legal Issues Quality Control

Hurricane Maria Tests Pharma Business Continuity Plans

Puerto Rico's slow recovery from Hurricane Maria provides insight into what happens when disaster strikes a node of the global pharmaceutical manufacturing network. Initial efforts to ward off US drug shortages focus on generic injectables that can't support expensive business continuity plans – but even critical prescription brands could be threatened if the US territory's power grid remains off line too long.

Manufacturing Scrip 100
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Company Information

  • Industry
  • Medical Devices
    • Infusion Therapy Equipment and Supplies
    • Monitoring Equipment & Devices
  • Therapeutic Areas
  • Non-Specific
  • Alias(es)
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • ICU Medical Inc.
  • Senior Management
  • Vivek Jain, Chmn. & CEO
    Scott Lamb, CFO
    Alison D Burcar, VP, Mktg.
    Richard A Costello, VP, Sales
  • Contact Info
  • ICU Medical Inc.
    Phone: (949) 366-2183
    951 Calle Amanecer
    San Clemente, CA 92673
    USA
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