# FDA 483 - Grato Holdings, Inc. - July 14, 2021

Source: https://www.keypedia.com/records/483/grato-holdings-inc/18dd63bd-16c4-4cec-9760-4f6cbed3357c

> FDA 483 for Grato Holdings, Inc. on July 14, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grato Holdings, Inc.
- Inspection Date: 2021-07-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Grato Holdings, Inc. in Woodbine, IA, revealed significant deficiencies across multiple areas of their drug manufacturing operations. The firm failed to properly calibrate laboratory equipment, conduct thorough investigations into product discrepancies, and maintain adequate computer system security for analytical data. Additionally, issues were noted with microbiological media testing and the cleaning and sanitization of raw material sampling utensils, indicating a broad lack of adherence to good manufacturing practices.

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## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)

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