FDA WARNING_LETTER - Siemens Healthcare Diagnostics, Inc. - February 09, 2012

An FDA inspection of Siemens Healthcare Diagnostics, Inc. in Newark, Delaware, from December 2011 to February 2012, revealed that the firm's in vitro diagnostic products are adulterated under section 501(h) of the Act, as manufacturing methods and controls do not conform to the Quality System regulation (21 CFR Part 820). The inspection identified three primary violations. First, the firm failed to establish and maintain adequate procedures for controlling nonconforming product (21 CFR 820.90(a)), frequently opting for "replace on complaint" instead of initiating required field corrections for significant product malfunctions. Second, procedures for rework were inadequate (21 CFR 820.90(b)(2)), with insufficient documentation of reevaluation activities or investigation into failure causes prior to rework. Third, the firm failed to establish and maintain adequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), as CAPAs lacked proper documentation of investigations, confirmation of root causes, or effective corrective/preventative actions. The firm's February 2012 response to the FDA 483 was deemed inadequate, lacking comprehensive documentation, systemic corrective actions, and clear timelines for implementation and training. Siemens must promptly correct these violations, provide a detailed response within fifteen business days, including documentation of systemic corrective actions and a timetable for completion. Failure to comply may result in regulatory actions, including seizure, injunction, civil penalties, and impact on federal contracts and product approvals.