FDA WARNING_LETTER - Ortho Clinical Diagnostics Gmbh - February 12, 2015

On September 3, 2015, the FDA issued a Warning Letter to Ortho-Clinical Diagnostics GmbH, a refurbishment facility for Class II Clinical Chemistry and Immunodiagnostics equipment in Neckargemund, Germany, following an inspection from February 9-12, 2015. The inspection revealed that the firm's devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: The firm failed to adequately document effectiveness checks for four specific CAPAs (2013-001, 2013-002, 2013-005, 2013-003). The firm's response was inadequate as it did not address local paper processes, language requirements, or provide justification for limited retrospective reviews and revised procedures/training. 2. **Failure to control nonconforming product (21 CFR 820.90(a))**: The firm failed to adequately investigate and document details of potentially affected products (chemicals, lot numbers, quantities) for nonconformance events #337393 and #20