Morton Salt Inc – FDA 483
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.
- Company
- Morton Salt Inc
- Product type
- drugs
ID · a0948819-3363-4eb3-b299-2f7a0aa9b743
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