Otsuka ICU Medical LLC

Form 483

Issued to: Hospira, Inc.

Austin, Texas, United StatesFEI 1628454Issued July 10, 2015

View Form 483 PDF

Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1628454.

Observations19

Issue DateJuly 10, 2015

StatusNo Warning Letter

Establishment TypeSterile Drug Manufacturer

Related Inspections6

Establishment Details

Firm: Otsuka ICU Medical LLC
Issued To: Hospira, Inc.
Location: Austin, Texas, United States
FEI Number: 1628454
Establishment Type: Sterile Drug Manufacturer
Product Type: Drugs
Issue Date: July 10, 2015
Country: United States

Inspection History, 2009 to 2024

NAI2

VAI3

OAI1

NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.

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Otsuka ICU Medical LLC FDA Form 483, Austin, Texas, July 10, 2015