FDA EIR - Avent S.A. De C.V. - October 12, 2006

An FDA inspection of Avent S.A. De C.V. in Nogales, Mexico, a medical device manufacturer and subsidiary of Kimberly Clark Health Care, was conducted from October 9-12, 2006. The inspection, part of the International Operations Group’s foreign inspections for medical device manufacturers, aimed to assess compliance with regulatory frameworks. Notably, the inspection revealed no major violations, Quality System Inspectional Technique (QSIT) or Good Manufacturing Practice (GMP) deviations, and no FDA 483 Inspectional Observation Form was issued. Furthermore, all issues from a previous inspection in 1990 had been satisfactorily resolved. During the inspection, an observation was made regarding the calibration of equipment used to verify critical limits in the manufacturing process. It was noted that certain equipment was not calibrated down to the minimum critical limit, meaning the calibration range did not fully cover the required operational specifications. In response, company management acknowledged the validity of this observation and indicated they would conduct internal discussions to implement necessary changes to ensure calibration procedures align with all minimum critical limits. The FDA also recommended a future inspection specifically focused on the newly acquired Ballard Medical product line to ensure its compliance with applicable U.S. regulations.