# FDA 483 - Grain Processing Corporation - February 13, 2020

Source: https://www.keypedia.com/records/483/grain-processing-corporation/000f1d1a-7cfa-4e6c-8f93-cef11cb6b9a5

> FDA 483 for Grain Processing Corporation on February 13, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grain Processing Corporation
- Inspection Date: 2020-02-13
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East VI
- Summary: An FDA inspection of Grain Processing Corporation in Muscatine, IA, an API manufacturer, revealed deficiencies in change control procedures. The firm failed to adequately evaluate the impact of changes to a drug substance filling line, leading to potential contamination and a subsequent customer complaint regarding out-of-specification moisture content in an EtOH product. This indicates a lack of proper control over manufacturing processes and product quality.

## Related Officers

- [Brian D. Nicholson](https://www.keypedia.com/people/brian-d-nicholson/83ea13dd-6753-468a-a0ca-19e3ef4158dd)
- [Peng Zhou](https://www.keypedia.com/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)

Company: https://www.keypedia.com/companies/grain-processing-corporation/ba7c7952-d853-4b39-82d3-2bb591585688

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-vi/4a1cadca-f04c-44d0-8d7a-4e1d6e583766