Medela Inc – FDA Warning Letter, Nov 1, 2010

On February 25, 2011, the FDA issued a Warning Letter to Medela, Inc. following an inspection from October 4 to November 1, 2010, at their McHenry, Illinois facility. The inspection revealed that Medela's breast pumps, breast pump kits, and pediatric feeding devices are adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act, as their manufacturing processes do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain adequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(a))**: This was evidenced by a lack of analysis of 14 Pump in Style Advanced (PNSA) electric breast pump complaints involving motors and transformers smoking or catching fire, and failure to identify actions for PNSA printed circuit boards with potential defects leading to low/loss of vacuum or power issues, which resulted in increased returns. Medela's response was inadequate as it lacked systemic corrective action and evidence of implementation. 2. **Failure to adequately establish and maintain complaint files (21 CFR 820.198(a))**: Many Return Material Authorizations (RMAs) communicating alleged deficiencies were not recognized or documented as complaints. Complaint files also lacked complete details, such as patient outcomes