FDA 483 - Morton Salt Inc - May 23, 2025

Morton Salt Inc. in Rittman, OH, an API manufacturer, was inspected and received a Form 483 with three observations. The inspection revealed significant deficiencies in their quality system, including inadequate investigations of out-of-specification results, deviations, and customer complaints, as well as a failure to validate analytical and equipment cleaning methods. Additionally, the firm failed to maintain complete laboratory control records, impacting data integrity and product quality.