# FDA 483 - Ingredion Incorporated - November 22, 2021

Source: https://www.keypedia.com/records/483/ingredion-incorporated/a745d679-bc7f-4c44-b15a-74f4693e4230

> FDA 483 for Ingredion Incorporated on November 22, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ingredion Incorporated
- Inspection Date: 2021-11-22
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Ingredion Incorporated in Indianapolis, IN, was cited for failing to establish and implement adequate written procedures for monitoring process controls. This deficiency is severe, as it directly contributed to three voluntary recalls of modified corn starch products due to metal contamination. The firm's existing mitigation strategies and nonconforming product procedures proved ineffective in preventing the release of contaminated products.

## Related Officers

- [investigator](https://www.keypedia.com/people/hans-t-meyers/27201300-ee56-4ad6-b04f-39ad9f216da6)
- [Brian J. Davis](https://www.keypedia.com/people/brian-j-davis/549057ed-e548-4747-b71f-2deb62d6b59f)

Company: https://www.keypedia.com/companies/ingredion-incorporated/a8d09180-7dcc-4c97-8fe1-ea929e5c9490

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0