# FDA 483 - Grant Industries,  Inc. - June 16, 2025

Source: https://www.keypedia.com/records/483/grant-industries-inc/0f515d2d-3815-4ae5-8488-b85c97078012

> FDA 483 for Grant Industries,  Inc. on June 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grant Industries,  Inc.
- Inspection Date: 2025-06-16
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Grant Industries, Inc. in Elmwood Park, NJ, a drug manufacturer, was inspected and cited for significant deficiencies across its quality control, production, laboratory, and training systems. Key issues include inadequate process and equipment validation, insufficient stability programs, poor computer system controls leading to data integrity concerns, and a lack of proper testing for raw materials like glycerin. These observations indicate a systemic failure to ensure drug product quality, purity, and strength.

## Related Documents

- [483 - 2020-08-21](https://www.keypedia.com/records/483/grant-industries-inc/7ba368ed-894b-484e-8ad5-c4ea2a66fc33)

## Related Officers

- [Suchan Kim](https://www.keypedia.com/people/suchan-kim/1acf9a36-036f-48a8-a8a4-caa290830e37)
- [Drug Investigator](https://www.keypedia.com/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)

Company: https://www.keypedia.com/companies/grant-industries-inc/bf60053c-0aa3-4217-b068-ef8b06b6bd27

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248