FDA Warning Letter — Ortho Clinical Diagnostics Gmbh

Case 457877 — FEI 3001665564

The FDA took a Warning Letter action against Ortho Clinical Diagnostics Gmbh on September 3, 2015 (Neckargemund, Germany). The action was issued by CDRH and concerns devices products. This facility has 2 recent FDA inspections on record.

Action Details

Facility
Ortho Clinical Diagnostics Gmbh
Date
September 3, 2015
Fiscal Year
2015
Product Type
Devices
Center
CDRH
Location
Neckargemund (Germany)