Covidien LP – FDA Warning Letter, Feb 9, 2012

On June 14, 2012, the FDA issued a Warning Letter to Covidien, Inc. following an inspection of their North Haven, Connecticut facility from January 13 to February 9, 2012. The inspection determined that Covidien manufactures surgical staples and single-use loading units, including the DUET Tissue Reinforcement System (TRS) Reload, which are considered devices under the Federal Food, Drug, and Cosmetic Act.

The devices were found to be adulterated because their 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 implement corrective and preventive actions (CAPA)** (21 CFR 820.100(a)): Despite numerous complaints, adverse events, and serious adverse events regarding the DUET TRS since May 2009, a CAPA investigation was not initiated until January 19, 2012, after the FDA inspection. Covidien's February 24, 2012, response was deemed inadequate as it did not describe or provide evidence of implemented corrections or corrective actions, including a retrospective review of complaints. 2. **Failure to promptly review, evaluate, investigate, and maintain complaints requiring FDA reporting** (21 CFR 820.198(d)): Covidien received reports of