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

Source: https://www.keypedia.com/records/483/grant-industries-inc/41ef8fcc-2571-42b4-8c0c-c7112ad4d960

> 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: During an inspection conducted from June 11 to June 16, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to an unnamed firm, citing significant deviations from current Good Manufacturing Practices (cGMP). The observations highlight critical issues across quality control, production, laboratory, and training systems. Key violations included the quality control unit's failure to adequately manage out-of-specification material, specifically releasing a reworked Zinc Oxide batch after multiple retests without stability assessment, and implementing unjustified changes to product specifications. The firm also lacked adequate production and process controls, evidenced by the absence of protocol-driven process validation studies for drug products and unvalidated critical laboratory equipment. Furthermore, the inspection revealed a deficient stability program, lacking forced degradation studies for analytical methods and inadequate evaluation of impurity detection during method validations. Computer systems for GMP operations were found to have insufficient controls, including a lack of second-person data review, an enabled data deletion function with administrative access, and an unvalidated inventory management system. Other issues included incomplete laboratory records, with unqualified secondary standards and absent documentation for solution preparations. Critical component testing was deficient, as incoming Glycerin USP was not tested for diethylene glycol and ethylene glycol. Finally, an employee performing critical FT-IR identification testing lacked documented training for the procedure. The firm is required to address these serious deficiencies with robust corrective actions to ensure product quality and regulatory compliance.

## 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/9e465cce-ba8b-48df-8c47-94fea43723c6

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