# FDA 483 - Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.) - April 24, 2019

Source: https://www.keypedia.com/records/483/synovis-life-technologies-inc-sub-of-baxter-intl-inc/3c6b7e8a-b893-42db-85d0-8bb8002c2e84

> FDA 483 for Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.) on April 24, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.)
- Inspection Date: 2019-04-24
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Synvisis Life Technologies, Inc. in Saint Paul, MN, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, including missing effectiveness checks and proper tracking of audit-related CAPAs. Additionally, process control procedures for products like Peri-Strip Dry Verifas Linear were found to be inadequately defined.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.keypedia.com/companies/synovis-life-technologies-inc-sub-of-baxter-intl-inc/c1b2c24e-11c2-4674-a1cd-8291d669f6f4

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d