Progress Report

On February 3, 2015, Atrium and three other affiliated Maquet companies reached an agreement concerning a Consent Decree (Decree) with the U.S. Food and Drug Administration (FDA). This voluntary agreement has been approved by a federal judge in New Hampshire and it establishes a framework that provides assurances to FDA that we will complete the improvements currently underway to strengthen our quality management system.

This agreement provides us with a clear path forward by which this division will operate while addressing the FDA’s inspectional observations and the company’s own internal quality evaluations.

We are committed to keeping you apprised of our progress and will be posting regular activity reports here in the future.

Over the last 7 months since entering into the Decree the following actions have been undertaken:

Hudson NH Facility

  • The facility in Hudson, NH was audited by Maquet’s third party auditor in April of 2015.
  • The Audit resulted in observations indicative of some compliance gaps that required correction.
  • The inspection verified that all FDA inspectional findings (Form 483 Observations) identified have been fully corrected or will be fully corrected with the completion of the work plan.
  • The audit responses and the required work-plan were sent to FDA within the required timeline.
  • The audit responses are in the process of being reviewed and certified by the third party auditor.
  • The work-plan was accepted by the FDA and the required items are currently on track to be completed by the 1st quarter of 2016.
  • Once all work-plan items are complete and are reviewed and accepted by the third party auditor, they will provide a written certification to the FDA.
  • Hudson will continue to be audited by the third party auditor every 6 months for one year after certification and then annually for an additional 4 years to ensure the facility maintains compliance with the Consent Decree and Quality System regulations.

Merrimack NH facility:

  • The new facility in Merrimack, NH was audited by Maquet’s third party inspector in May of 2015.
  • The Audit resulted in some observations indicative of compliance gaps that required correction
  • The audit response was sent to FDA within the required timeline and the third party auditor confirmed that the corrective actions Atrium has taken are adequate and have been appropriately implemented. This was provided to the FDA.
  • Merrimack will continue to be audited by the third party auditor every year for a period of 4 years to ensure the facility maintains compliance with the Consent Decree and Quality System regulations.

Wayne NJ facility:

  • The facility in Wayne, NJ was audited by Maquet’s third party auditor in August of 2015.
  • The Audit resulted in some observations indicative of compliance gaps that required correction
  • The audit report from Quintiles was issued on September 21, 2015. A response is due within 30 days of the report being issued.
  • Wayne will continue to be audited by the third party auditor every year for a period of 4 years to ensure the facility maintains compliance with the Consent Decree and Quality System regulations.