# FDA 483 - Morton Salt Inc - May 23, 2025

Source: https://www.globalkeysolutions.net/records/483/morton-salt-inc/c5503783-8ea1-4563-93c2-d233cc924d79

> FDA 483 for Morton Salt Inc on May 23, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Morton Salt Inc
- Inspection Date: 2025-05-23
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: 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.

## Related Documents

- [EIR - 2025-05-23](https://www.globalkeysolutions.net/records/eir/morton-salt-inc/642558db-1c66-4fb5-b265-e3424e0c1aee)

## Related Officers

- [Pamela N. Agaba](https://www.globalkeysolutions.net/people/pamela-n-agaba/1ad981d6-8074-4572-8648-7d35f41e94f6)
- [investigator](https://www.globalkeysolutions.net/people/geoffrey-k-kilili/b00aeedf-95bd-4ccf-a23e-6e12e60249c4)

Company: https://www.globalkeysolutions.net/companies/morton-salt-inc/823fa877-7377-4020-9234-37328296eec4

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22