# FDA 483 - ITG-Medev, Inc. - October 22, 2021

Source: https://www.keypedia.com/records/483/itg-medev-inc/0d6f4771-c34f-42a8-a1d0-80f97f1d7102

> FDA 483 for ITG-Medev, Inc. on October 22, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ITG-Medev, Inc.
- Inspection Date: 2021-10-22
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of ITG-Medev, Inc. in San Francisco, CA, revealed significant deficiencies in their quality system. The firm failed to adequately document process validation activities, specifically regarding sterilization dosage ranges. Additionally, the inspection found that corrective and preventive action activities and their results were not documented, indicating a lack of control over quality issues.

## Related Documents

- [483 - 2018-06-06](https://www.keypedia.com/records/483/itg-medev-inc/210fe425-302f-4133-9aa8-74d9ab0eac24)

## Related Officers

- [Kenya Destin](https://www.keypedia.com/people/kenya-destin/1a367d64-8171-4dfd-bb1f-78d8b96a99f5)
- [Consumer Safety Officer](https://www.keypedia.com/people/suzanne-m-healy/a4159f42-8968-4dec-89e3-46a5412bc47a)
- [investigator](https://www.keypedia.com/people/elizabeth-a-dakan/f701338d-0484-431b-8bd5-9db442b5f079)

Company: https://www.keypedia.com/companies/itg-medev-inc/cecf4e84-75d6-4850-a925-0afa2e66905f

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b