# FDA 483 - Atrium Medical Corporation - October 01, 2013

Source: https://www.globalkeysolutions.net/records/483/atrium-medical-corporation/756ee7c1-3cab-4902-b899-e1aa415c173b

> FDA 483 for Atrium Medical Corporation on October 01, 2013. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Atrium Medical Corporation
- Inspection Date: 2013-10-01
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Atrium Medical Corporation in Hudson, NH, revealed multiple significant deficiencies in their quality system for medical device manufacturing. The firm failed to adequately validate processes, monitor validated parameters, and establish effective corrective and preventive actions. Additionally, the company did not submit required Medical Device Reports (MDRs) within the mandated timeframe and maintained inadequate complaint files.

## Related Documents

- [483 - 2016-07-13](https://www.globalkeysolutions.net/records/483/atrium-medical-corporation/2f2fc98d-fdb5-4495-9e02-a62568002cb2)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/stephen-c-smith/426649fa-0e5b-4b35-ba41-636512a06a48)
- [issuing_officer](https://www.globalkeysolutions.net/people/maura-rooney/b9731b44-8033-4add-9863-545851b86bf7)

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