# FDA 483 - Artivion, Inc - March 31, 2023

Source: https://www.keypedia.com/records/483/artivion-inc/e75a540f-30c1-401b-9ee8-ee4cdbf56e04

> FDA 483 for Artivion, Inc on March 31, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Artivion, Inc
- Inspection Date: 2023-03-31
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Artivion, Inc. in Kennesaw, GA, was inspected and cited for significant deficiencies across its quality system. The inspection revealed inadequate procedures for controlling nonconforming products, insufficient documentation and approval of process validation activities, and poorly established corrective and preventive action procedures. Additionally, design verification failed to ensure that design outputs met input requirements for product labeling.

## Related Documents

- [483 - 2003-02-14](https://www.keypedia.com/records/483/artivion-inc/03061550-2828-460f-9834-9b7cce079bd2)
- [483 - 2018-08-08](https://www.keypedia.com/records/483/artivion-inc/ac594da7-b44a-47cc-a976-a6fea3066a5c)

## Related Officers

- [Mary A. Millner](https://www.keypedia.com/people/mary-a-millner/bd8911cf-849d-41d2-ae12-dd4bad66e798)
- [issuing_officer](https://www.keypedia.com/people/inga-m-warr/f27805b8-c2ba-4af5-bf5e-ff2e2f511ec1)

Company: https://www.keypedia.com/companies/artivion-inc/484ce438-d451-4d95-ab4c-726a2dc02c92

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7