# FDA 483 - Artivion, Inc - August 08, 2018

Source: https://www.keypedia.com/records/483/artivion-inc/ac594da7-b44a-47cc-a976-a6fea3066a5c

> FDA 483 for Artivion, Inc on August 08, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Artivion, Inc
- Inspection Date: 2018-08-08
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Cryolife, Inc. in Kennesaw, GA, revealed significant deficiencies in design validation for their patch products. The firm also failed to properly design, maintain, and monitor manufacturing equipment, including issues with preventive maintenance schedules and malfunctioning freezer alarms for cryopreserved allografts. These findings indicate a lack of adequate quality system controls for device manufacturing and tissue storage.

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## Related Officers

- [Tamara A. Stephens](https://www.keypedia.com/people/tamara-a-stephens/32d1ea92-8ebd-4cd5-9c98-1e53aea35d44)
- [investigator](https://www.keypedia.com/people/rhonda-alexander/349a6c4d-5cc1-4a7a-9c3c-1a85da01e7db)
- [Dawn M. Braswell](https://www.keypedia.com/people/dawn-m-braswell/6a66fdbb-fff8-4b4b-9f06-320464957b87)
- [Latonya T Jiggetts](https://www.keypedia.com/people/latonya-t-jiggetts/a3cd08d6-c3af-4594-b6c9-b23b011aa9c5)
- [investigator](https://www.keypedia.com/people/brantley-s-collins/c806aac1-3d89-4427-8aeb-6d9db6dfc2f4)

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