FDA 483 - Morton Salt Inc

The inspection of Morton Salt Inc. in Grand Saline, TX, revealed significant deficiencies in quality control, data integrity, and facility maintenance. Observations included inadequate investigation of out-of-specification results, lack of data backup for laboratory instruments, and failure to establish proper specifications and microbial controls for API production. Additionally, the firm exhibited poor laboratory record-keeping, unsuitable storage conditions for stability samples, and a lack of comprehensive quality reviews, with some issues being recurrent from a previous inspection.