FDA 483 - Space Maintainers Lab - October 03, 2024

An FDA inspection of Space Maintainers Lab, a medical device manufacturer in Chatsworth, CA, revealed two significant observations. The firm failed to establish adequate procedures for device history records, specifically for anti-snoring and jaw positioning class II medical devices. Additionally, the inspection found that procedures for training and identifying training needs were not adequately established, with management lacking documented formal training for Quality System Regulation.