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 2250051.
Observations4
Issue DateDecember 09, 2022
StatusNo Warning Letter
Related Inspections10
Establishment Details
Firm
Ortho-Clinical Diagnostics, Inc.
Location
Raritan, New Jersey, United States
FEI Number
2250051
Product Type
Biologics
Issue Date
December 09, 2022
Country
United States
Inspection History, 2009 to 2025
NAI5
VAI5
NAI means No Action Indicated. VAI means Voluntary Action Indicated.