FDA WARNING_LETTER - CORPAK MedSystems, Inc. - January 04, 2013

On November 26, 2012, through January 4, 2013, an FDA inspection of Corpak MedSystems, Inc. in Buffalo Grove, Illinois, revealed that their disposable medical devices, including enteral feeding bags, administration sets, feeding tubes, catheters, gastronomy devices, and the Cortrak Enteral Access System, were adulterated. The manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish adequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(a))**: CAPA (b)(4) was closed without identifying actions to prevent recurrence of inaccurate transmitting stylet tip deployment or verifying effectiveness. 2. **Failure to adequately document process validation activities (21 CFR 820.75(a))**: Validation (b)(4) for Cortrak Tube Product Performance Qualification did not document 100% in-process functional testing or rejected stylets (e.g., 22 from Lot (b)(4), 11 from Lot (b)(4), 27 from Lot (b)(4)). 3. **Failure to control nonconforming product (21 CFR 820.90(a))**: Over 3,000 transmitting stylets