FDA 483 - Artivion, Inc - February 14, 2003

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