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 3001665564.
Observations4
Issue DateFebruary 12, 2015
StatusNo Warning Letter
Related Inspections2
Establishment Details
Firm
Ortho Clinical Diagnostics Gmbh
Location
Neckargemund, -, Germany
FEI Number
3001665564
Product Type
Devices
Issue Date
February 12, 2015
Country
Germany
Inspection History, 2015 to 2016
NAI1
OAI1
NAI means No Action Indicated. OAI means Official Action Indicated.