# FDA 483 - Fuller Industries, Inc - February 17, 2023

Source: https://www.keypedia.com/records/483/fuller-industries-inc/4024682f-109b-45e2-9f01-de9b879bfe5f

> FDA 483 for Fuller Industries, Inc on February 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fuller Industries, Inc
- Inspection Date: 2023-02-17
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Fuller Industries, Inc., an OTC manufacturer in Great Bend, KS, was cited for significant deficiencies in laboratory controls, quality systems, and record-keeping during an FDA inspection. Observations included unvalidated test methods, uncontrolled procedures, and a failure to investigate out-of-specification results for antibacterial hand soap, which was subsequently released for distribution. The firm also lacked proper written procedures for product evaluations, supplier qualification, and document approval, indicating a systemic breakdown in quality assurance.

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## Related Officers

- [Torrey M. Ward](https://www.keypedia.com/people/torrey-m-ward/e3021951-811e-45a0-a029-69c7cc862fcf)

Company: https://www.keypedia.com/companies/fuller-industries-inc/c156f0dc-cacf-47b2-9cc5-007269d292ff

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8