# FDA 483 - GoodFibers LLC - August 19, 2022

Source: https://www.keypedia.com/records/483/goodfibers-llc/ed71c8d3-ed34-46de-b21c-0a98fdee600c

> FDA 483 for GoodFibers LLC on August 19, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GoodFibers LLC
- Inspection Date: 2022-08-19
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: GoodFibers LLC, an OTC drug manufacturer in Phoenix, AZ, was cited with six observations during an FDA inspection. The firm demonstrated significant deficiencies in its stability program, including a lack of specific test methods and uncontrolled storage conditions for stability samples. Additionally, the inspection revealed failures to investigate out-of-specification results, inadequate laboratory controls for component and finished product testing, and issues with equipment cleaning validation and water system validation.

## Related Officers

- [Joel D. Hustedt](https://www.keypedia.com/people/joel-d-hustedt/29440042-08dd-4dce-be48-b55f8e1d7080)
- [investigator](https://www.keypedia.com/people/heidy-c-perales/fdf71c74-8cb7-41b5-9070-6b8eb11cb404)

Company: https://www.keypedia.com/companies/goodfibers-llc/5d72b71f-43a7-4554-94b4-c3378654df06

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6