# Fuller Industries, Inc – FDA 483, Jul 23, 2026

Source: https://www.keypedia.com/records/483/fuller-industries-inc/552fdf17-56cc-41c5-9e66-b3e1a638181c

> FDA 483 for Fuller Industries, Inc on July 23, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fuller Industries, Inc
- Inspection Date: 2026-07-23
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: Fuller Industries Inc, an OTC drug manufacturer in Great Bend, KS, was cited for significant deficiencies across multiple areas during an FDA inspection. The observations, many of which are repeats, highlight severe issues with equipment cleaning validation, component testing, laboratory controls including data integrity and environmental conditions, stability testing, and discrepancy investigations. These findings indicate a systemic lack of adherence to cGMP requirements, posing risks to product quality and patient safety.

## Related Documents

- [483 - 2025-03-26](https://www.keypedia.com/records/483/fuller-industries-inc/0d5aaf3f-9136-4cc1-a017-24e6cbd2bbd5) — date: March 26, 2025
- [483 - 2023-02-17](https://www.keypedia.com/records/483/fuller-industries-inc/4024682f-109b-45e2-9f01-de9b879bfe5f) — date: February 17, 2023

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/eric-d-bowles/bb6c783b-0933-4231-b79e-c591cbc50104)
- [Jean Claude Garay](https://www.keypedia.com/people/jean-claude-garay/e85f215e-5a7e-40f7-9214-74b18de1792a)

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

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79
