# FDA 483 - Grato Holdings, Inc. - September 19, 2025

Source: https://www.globalkeysolutions.net/records/483/grato-holdings-inc/6a8c9302-89ab-4859-a743-ee0b79a51459

> FDA 483 for Grato Holdings, Inc. on September 19, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grato Holdings, Inc.
- Inspection Date: 2025-09-19
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: Grato Holdings, Inc. in Woodbine, IA, received an FDA Form 483 for deficiencies in its equipment and utensil cleaning procedures. The firm failed to scientifically assess the adequacy of its cleaning methods, especially for new raw materials like progesterone, and did not update its risk matrix to prevent contamination from various substances, including hormones and pathogenic organisms. These issues indicate a risk of contamination that could compromise drug product safety, identity, strength, quality, or purity.

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## Related Officers

- [Tyler M. Peterson](https://www.globalkeysolutions.net/people/tyler-m-peterson/207310ee-260c-4618-a515-9895a56e2ede)

Company: https://www.globalkeysolutions.net/companies/grato-holdings-inc/c4d08434-07cf-4712-94fe-865ffad4ef6c

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