carefusion corp – FDA Warning Letter, Jan 26, 2012

On January 23-26, 2012, an FDA inspection of CareFusion Corp dba Productos Urologos De Mexico S.A. De C.V. in Mexicali, Mexico, identified that the firm's Airlife Oxygen Mask, Air Life Misty Max 10 Nebulizers, and Airlife Nasal Oxygen Cannula devices were adulterated. The manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System regulation (21 CFR Part 820).

Violations included: 1. **Failure to establish and maintain adequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(a))**: A CAPA file (TS-10-002-C) had two extensions beyond the permitted two, and a corrective action was transferred to a new CAPA (TS-11-011-C) without being conducted. The firm's response to implement a new global CAPA policy was deemed inadequate as it lacked evidence of implementation, risk determination, effectiveness verification, and systemic corrective actions for 15 open CAPAs.

2. **Failure to adequately validate processes where results cannot be fully verified by subsequent inspection and test (21 CFR 820.75(a))**: * The firm's process validation procedure (MX-0710-0