# FDA 483 - ITG-Medev, Inc. - June 06, 2018

Source: https://www.globalkeysolutions.net/records/483/itg-medev-inc/210fe425-302f-4133-9aa8-74d9ab0eac24

> FDA 483 for ITG-Medev, Inc. on June 06, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ITG-Medev, Inc.
- Inspection Date: 2018-06-06
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: ITG Medev Inc. in San Francisco, CA, was inspected and received a Form FDA-483 with seven observations. The inspection revealed significant deficiencies in the firm's quality system, including a failure to revalidate a sterilization process after changing sterilizers for their Omiderm wound dressing, inadequate procedures for finished device acceptance, and a complete lack of quality audits and management reviews for at least five years. These issues indicate a severe breakdown in quality management practices for a manufacturer of sterile medical devices.

## Related Documents

- [483 - 2021-10-22](https://www.globalkeysolutions.net/records/483/itg-medev-inc/0d6f4771-c34f-42a8-a1d0-80f97f1d7102)

## Related Officers

- [Sara M. Richardson](https://www.globalkeysolutions.net/people/sara-m-richardson/460de568-e9ad-49bd-bf63-291bea7731db)

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

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