FDA 483 - Chemsil Silicones Inc - October 22, 2024

An FDA inspection of Chemsil Silicones Inc, a Class II medical device contract manufacturer in Chatsworth, CA, revealed two significant observations. The firm's procedures for equipment cleaning and maintenance were found to be inadequate, specifically lacking details for rinsing mixing tanks. Additionally, a viscometer used for testing personal lubricant was out of its calibration schedule, indicating a failure in documenting equipment calibrations.