Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1628454.
Observations5
Issue DateMarch 10, 2017
StatusNo Warning Letter
Related Inspections6
Establishment Details
Firm
Otsuka ICU Medical LLC
Location
Austin, Texas, United States
FEI Number
1628454
Product Type
Drugs
Issue Date
March 10, 2017
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.