Sanmina-SCI AB – FDA Warning Letter, Dec 12, 2013

On April 11, 2014, the FDA issued a Warning Letter to Sanmina SCI AB following an inspection from December 9-12, 2013, at their Ornskoldsvik, Sweden facility. The inspection revealed that the firm's Afinion AS 100 Analyzer for Axis-Shield (Norway) devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with the Quality System regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: The firm did not identify actions to correct and prevent recurrence of nonconforming product and failed to verify or validate corrective actions. For example, Corrective Action M3292 was closed without an identified corrective action or verification of effectiveness, despite high Return Material Authorization (RMA) percentages. Corrective Action M3766 lacked verification activities for implemented corrective actions. The firm's response was deemed inadequate as it lacked documentation of implemented corrections, a timeline, justification for the omission, and evidence of systemic corrective action. 2. **Failure to validate processes (21 CFR 820.75(a))**: Process validation for the (b)(4) process was inadequate, specifically lacking a performance qualification (