# FDA 483 - Artivion, Inc - February 14, 2003

Source: https://www.keypedia.com/records/483/artivion-inc/03061550-2828-460f-9834-9b7cce079bd2

> FDA 483 for Artivion, Inc on February 14, 2003. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Artivion, Inc
- Inspection Date: 2003-02-14
- Product Type: Devices
- Office Name: Atlanta District Office
- Summary: The FDA Form 483 documents observations from an inspection of a firm, identifying significant deficiencies in their operations related to allograft processing and quality systems.

**Key Violations and Observations:**

*   **Allograft Retrieval and Infection Control:** The firm failed to retrieve at least twelve distributed allografts associated with reported *Clostridium, Candida*, or *E. Coli* infections, processed prior to an FDA Recall Order on August 12, 2002. No action was taken by the inspection's initiation on February 5, 2003.
*   **Review of Processed Allografts:** A "look back" review of allografts processed between 1998-2002 lacked an established plan, procedures, or corrective action request (CAR).
*   **Complaint Handling Deficiencies:**
    *   A complaint received on January 2, 2003, via MedWatch regarding an *Aspergillus*-contaminated heart valve (also reported with *Staphylococcus* infection) was not documented, investigated, or followed up on, and no MDR was filed.
    *   Many complaint files were incomplete or disorganized. For example, complaint #02-5210367, concerning a femoral vein infection with *Corynebacterium*, lacked a summary and complete follow-up.
    *   As of February 10, 2003, at

## Related Documents

- [483 - 2018-08-08](https://www.keypedia.com/records/483/artivion-inc/ac594da7-b44a-47cc-a976-a6fea3066a5c)
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## Related Officers

- [Vascular Neurologist/Neurohospitalist/Medical Officer](https://www.keypedia.com/people/claudette-d-brooks/10f30b8f-2d20-4f92-84c1-862b31b81ce1)

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