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 1000136573.
Observations2
Issue DateMay 22, 2025
StatusNo Warning Letter
Related Inspections5
Establishment Details
Firm
Ortho-Clinical Diagnostics, Inc.
Location
Rochester, New York, United States
FEI Number
1000136573
Product Type
Devices
Issue Date
May 22, 2025
Country
United States
Inspection History, 2012 to 2025
NAI1
VAI4
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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