# FDA 483 - Atrium Medical Corporation - July 13, 2016

Source: https://www.globalkeysolutions.net/records/483/atrium-medical-corporation/2f2fc98d-fdb5-4495-9e02-a62568002cb2

> FDA 483 for Atrium Medical Corporation on July 13, 2016. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Atrium Medical Corporation
- Inspection Date: 2016-07-13
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Atrium Medical Corporation received a Form 483 citing significant deficiencies across multiple quality system areas. The observations primarily focused on inadequate validation of sterilization and manufacturing processes for devices like iCAST/V12 stents and chest drains, as well as failures in design verification, packaging integrity, and shelf-life studies. Additionally, the firm demonstrated systemic issues with its corrective and preventive action system, control of non-conforming product, equipment maintenance, complaint handling, and timely submission of Medical Device Reports for serious injuries and malfunctions.

## Related Documents

- [483 - 2013-10-01](https://www.globalkeysolutions.net/records/483/atrium-medical-corporation/756ee7c1-3cab-4902-b899-e1aa415c173b)

## Related Officers

- [Tamara Rosbury](https://www.globalkeysolutions.net/people/tamara-rosbury/2f2ae190-62e0-4c3d-9463-e2b990fe792b)

Company: https://www.globalkeysolutions.net/companies/atrium-medical-corporation/d7f808ee-1045-4b9c-8ce0-d00d14d2bbda

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