483
Morton Salt IncFDA 483 - Morton Salt Inc
Record Details
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
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ID · a0948819-3363-4eb3-b299-2f7a0aa9b743