# FDA 483 - Grato Holdings, Inc. - December 06, 2019

Source: https://www.keypedia.com/records/483/grato-holdings-inc/1cfb6b3e-d7ed-415c-bcc9-ec1f53aff862

> FDA 483 for Grato Holdings, Inc. on December 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grato Holdings, Inc.
- Inspection Date: 2019-12-06
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Grato Holdings, Inc. in Woodbine, IA, was inspected from December 2-6, 2019, and received a Form 483 with six observations. The inspection revealed significant deficiencies in method validation for microbial testing, inadequate cleaning validation, and issues with raw material sampling. Additionally, the firm failed to ensure product identity and strength, properly investigate customer complaints, and maintain complete records of testing method modifications.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)
- [Regulatory Counsel, CDER Compliance, Office of Manufacturing Quality](https://www.keypedia.com/people/emilie-e-kahn/fac179e5-478f-4e75-9632-40d921f44a8f)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8