# FDA 483 - Gojo Industries - November 07, 2025

Source: https://www.keypedia.com/records/483/gojo-industries/2ac59b38-99f0-4145-b044-a5770a89d9f8

> FDA 483 for Gojo Industries on November 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gojo Industries
- Inspection Date: 2025-11-07
- Product Type: drugs
- Summary: Gojo Industries, a non-sterile drug manufacturer located in Wooster, OH, underwent an FDA inspection from November 3 to November 7, 2025. The inspection resulted in several significant observations detailed in a Form FDA 483, indicating deviations from regulatory expectations under the Federal Food, Drug, and Cosmetic Act.
A primary concern highlighted was the inadequacy of laboratory controls. Gojo Industries failed to test for all known and unknown impurities in both bulk materials and finished drug products, specifically noting issues with the analysis of certain impurities like (b)(4) and (b)(4). This oversight was particularly critical given documented cavitation events leading to impurity formation, affecting substantial quantities of distributed products, including (b)(4) Gels and other OTC drugs manufactured between 2023 and 2025.
Additionally, the firm's written stability program was found deficient; its test methods were not reliably stability-indicating or capable of adequately identifying and quantifying impurities to ensure product safety and quality over time. Concerns were also raised regarding the quality control unit, where the analytical laboratory manager held administrative software privileges while simultaneously performing method development and analytical testing, suggesting potential issues with adherence to established procedures and segregation of duties.
In response to these observations, Gojo Industries is expected to thoroughly investigate each finding, develop, and implement comprehensive corrective and preventive actions to ensure full compliance with good manufacturing practices and uphold product quality and public health. The firm has the opportunity to discuss its proposed actions with the FDA.

## Related Documents

- [483 - 2022-08-05](https://www.keypedia.com/records/483/gojo-industries/b5c21bb4-6dd4-4495-9503-36cc5c7f5d59)
- [483 - 2025-11-07](https://www.keypedia.com/records/483/gojo-industries/b027308f-5138-4fd5-9622-f0b7c5e3ca51)

## Related Officers

- [Martin M. Kimani](https://www.keypedia.com/people/martin-m-kimani/fbc296cc-e80e-46f4-a34a-848c8b20da05)

Company: https://www.keypedia.com/companies/gojo-industries/a14e2158-de5a-44b4-b6d8-7fdcb1e5c175