# FDA 483 - Morton Salt Inc - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/morton-salt-inc/a0948819-3363-4eb3-b299-2f7a0aa9b743

> FDA 483 for Morton Salt Inc on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Morton Salt Inc
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: 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.

## Related Officers

- [David Anderson, Supervisor OPQ/OPMA](https://www.globalkeysolutions.net/people/david-anderson-supervisor-opqopma/2dd6e66a-50a6-41ae-bf0c-b78f51b34764)
- [Milva Melendez, SCSO (Lead Investigator)](https://www.globalkeysolutions.net/people/milva-melendez-scso-lead-investigator/53a03bc2-db78-47e7-9fc3-559b193cc420)

Company: https://www.globalkeysolutions.net/companies/morton-salt-inc/e1b2d8e8-ae09-4a7a-9f38-e4b1df62a587

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321
