# FDA 483 - Abbott Vascular Inc - November 15, 2007

Source: https://www.globalkeysolutions.net/records/483/abbott-vascular-inc/a1ab46e4-065d-40b4-a42e-c17173807070

> FDA 483 for Abbott Vascular Inc on November 15, 2007. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbott Vascular Inc
- Inspection Date: 2007-11-15
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Abbott Vascular-Cardiac Therapies in Temecula, CA, was inspected regarding its medical device manufacturing, specifically the Xience V RX Everolimus Eluting Coronary Stent System. The inspection revealed significant deficiencies across design control, process validation, equipment control, and documentation practices. Issues included inadequate acceptance criteria, incomplete validation studies, lack of contamination prevention, and insufficient calibration and complaint handling procedures.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/bichsa-tran/6d902c39-50d1-4ee5-84db-2050933cf17b)
- [Sumit Sen](https://www.globalkeysolutions.net/people/sumit-sen/600a70b5-92f0-4ac7-8dc8-95918edf827e)
- [Supervisory Consumer Safety Officer](https://www.globalkeysolutions.net/people/mark-c-saale/0e5af086-8319-4499-878e-5bd94e66ea69)
- [Sonya L. Karsik](https://www.globalkeysolutions.net/people/sonya-l-karsik/c24603b9-5ca0-46f5-861a-b367155b0def)
- [Director of Investigations Branch](https://www.globalkeysolutions.net/people/katherine-e-jacobitz/9a713b44-95c4-43a2-83bb-8d30062d8345)

Company: https://www.globalkeysolutions.net/companies/abbott-vascular-inc/e3cfce73-cc19-4e69-b30a-54dee1543d8a

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6