# FDA 483 - Atrium Medical Corporation - August 02, 2018

Source: https://www.globalkeysolutions.net/records/483/atrium-medical-corporation/738cb61e-bd80-40f6-955a-a7ec15a16c71

> FDA 483 for Atrium Medical Corporation on August 02, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Atrium Medical Corporation
- Inspection Date: 2018-08-02
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: The FDA inspection of Atrium Medical Corporation in Merrimack, NH, revealed critical deficiencies in their quality system, particularly concerning the manufacture of iCAST/V12 vascular stents. The firm failed to adequately control bacterial endotoxin and bioburden contamination, validate processes, and document corrective and preventive actions. Additionally, issues were noted with equipment calibration and the timely submission of Medical Device Reports for injuries and malfunctions.

## Related Documents

- [WARNING_LETTER - 2012-09-07](https://www.globalkeysolutions.net/records/warning_letter/atrium-medical-corporation/b7b52ef0-39cd-4e26-bdf6-92606930f3e7)
- [483 - 2020-02-10](https://www.globalkeysolutions.net/records/483/atrium-medical-corporation/c1f59260-0cd9-499d-b4b1-9217859385ad)
- [483 - 2022-09-06](https://www.globalkeysolutions.net/records/483/atrium-medical-corporation/9f765a95-4914-4fc6-837e-c626f60ec74d)
- [483 - 2024-11-26](https://www.globalkeysolutions.net/records/483/atrium-medical-corporation/e5f6f83a-1e7e-48dc-b0a6-bbfb1c0edcf4)

## Related Officers

- [Diane M Bitor](https://www.globalkeysolutions.net/people/diane-m-bitor/7504dc8e-b096-462b-977c-3eddaf951088)
- [Investigator](https://www.globalkeysolutions.net/people/stephen-c-smith/426649fa-0e5b-4b35-ba41-636512a06a48)
- [Eric C. Schmitt](https://www.globalkeysolutions.net/people/eric-c-schmitt/f2716c8c-f06e-4519-a1e7-63a3ef6e07fb)

Company: https://www.globalkeysolutions.net/companies/atrium-medical-corporation/a210e43f-6ec7-4e83-83ee-1650b1cedd35

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7