# FDA WARNING_LETTER - Atrium Medical Corporation - September 07, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/atrium-medical-corporation/b7b52ef0-39cd-4e26-bdf6-92606930f3e7

> FDA WARNING_LETTER for Atrium Medical Corporation on September 07, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Atrium Medical Corporation
- Inspection Date: 2012-09-07
- Product Type: Devices
- Office Name: New England District Office
- Summary: On October 11, 2012, the FDA issued a Warning Letter to Atrium Medical Corporation following an inspection from July 31 to September 7, 2012. The inspection revealed that Atrium's medical devices, including C-QUR mesh, V12 and iCast Covered Stents, and Express Pre-Filled Chest Drains, were adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act. This was due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included:
1.  **Failure to validate the Ethylene Oxide (ETO) sterilization process (21 CFR 820.75(a))**: The firm could not demonstrate that the single process challenge device (PCD) used was representative of all 39 devices across six product families. Documentation for the PCD model and lot number was also missing. Atrium's response was inadequate, requiring documentation of successful re-validation and a plan to prevent recurrence.
2.  **Failure to investigate complaints involving device failure (21 CFR 820.198(c))**: Four complaints related to C-QUR mesh infections were closed without obtaining sample culture results or further investigation. The complaint procedure lacked instructions for collecting detailed information, leading to missing

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## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/mutahar-shamsi/f1ed0c75-3167-41cb-a918-130aa6d0fb07)
- [Joseph P. De Paolo](https://www.globalkeysolutions.net/people/joseph-p-de-paolo/19468b0d-456b-4184-90f6-6dc9a54a8be7)

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

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144