FDA WARNING_LETTER - Cordis LLC - October 13, 2010

An FDA inspection of Cordis LLC's San German, Puerto Rico facility, conducted from September 22 to October 13, 2010, revealed that the firm's Class III interventional cardiovascular devices are adulterated. The manufacturing, packing, storage, or installation methods and controls do not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820).

Key violations include: 1. **Corrective and Preventive Action (CAPA) Plan Failure (21 C.F.R. § 820.100):** CAPA plan 2192, opened on November 20, 2008, to address Design Verification (DV) Protocol (b)(4) test failures for stent catalog numbers, failed to prevent nonconforming products. Subsequent testing on Cypher Bx commercial products confirmed marketed devices also failed the SEU test. Further incidents in July and August 2009, involving Cypher US RX lots, showed stents failing to expand completely, despite initial compliance tests. The firm's determination that no field action was warranted for distributed lots was deemed objectionable, as compliance with the (b)(4) design specification is critical for patient safety.

2. **Process Control Procedures Failure (21 C.F.R. § 820.7