Inspections, Compliance, Enforcement, and Criminal Investigations
Atossa Genetics Inc. Response Letter 3/12/13
|1616 Eastlake Ave E. Suite 510|
Seattle, WA 98102
March 12, 2013
Charles M. Breen
FDA District Director, Seattle Office
22215 26th Ave SE, Suite 210
Bothell, WA 98021
Charles M. Breen,
To address the Warning Letter SEA 13-13 received on February 20, 2013, Atossa Genetics, Inc. has prepared this response which includes the documentation of the corrections undertaken to date as well as the Company's planned corrective/preventive actions and timeline. Atossa Genetics, Inc. recognizes FDA's concerns and will take prompt action to ensure the Atossa Genetics, Inc. quality system is in compliance with regulatory requirements. Although deficiencies were found to exist in the firm's quality system, we. do not believe that there is any evidence of safety related issues having occurred.
It is our intent to comply fully with the FDA Quality System regulation. Atossa Genetics, Inc. plans to submit its Quality Plan describing how the Company plans to prevent the same violations, or similar violations, from recurring in our quarterly reports to the agency.
Also, the Company has contracted independent regulatory compliance and quality experts to evaluate the Company's Quality System to determine if any further revisions are required to ensure compliance to the QSR regulations. This assessment will include recommendations for the staffing requirements to maintain a compliant system.
Included in the response is a spreadsheet listing all commitments Atossa Genetics, Inc. has made in response to this Warning Letter.
FDA's policy states that responses to Warning Letters will be posted on the FDA website at the Warning Letter recipients' request. We therefore request that this letter be posted on FDA's website.
In addition, Atossa Genetics, Inc. will submit a new SlO(k) submission for the MASCT System.
Please let me know if there are questions or clarifications regarding this response. We would be pleased to meet with you to discuss the report and our efforts.
Steven C. Quay, MD, PhD, FCAP
CEO & President, Atossa Genetics, Inc.
1616 Eastlake Ave E, Suite 360
Seattle, WA 98102