Atossa Genetics Inc. Announces Successful Closure of FDA Inspections
(firmenpresse) - SEATTLE, WA -- (Marketwired) -- 12/05/14 -- (NASDAQ: ATOS) today announced that it has received "establishment inspection reports," or EIRs, from the U.S. Food and Drug Administration, Office of Compliance, related to inspections conducted by the FDA in 2012 and 2014. Issuance of the EIRs means that the FDA has now closed those inspections.
Dr. Steven C. Quay, Chairman, CEO and President, stated, "Over the past 18 months, we have worked diligently to ensure that all observations noted during the inspections were being resolved expeditiously. I would like to thank the entire Atossa team for their tireless commitment to this effort. We will continue to devote significant resources to ensure that our regulatory compliance meets current standards worldwide with respect to our business."
Atossa Genetics Inc. is focused on improving breast health through the development of laboratory services, medical devices and therapeutics. The laboratory services are being developed by its subsidiary, The National Reference Laboratory for Breast Health, Inc. The laboratory services and the Company''s medical devices are being developed so they can be used as companions to therapeutics to treat various breast health conditions. For additional information, please visit .
Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with actions by the FDA, the outcome or timing of regulatory clearances needed by Atossa to sell its products, responses to regulatory matters, Atossa''s ability to continue to manufacture and sell its products, recalls of products, the efficacy of Atossa''s products and services, performance of distributors, estimated future expenses and cash needs, whether Atossa can launch in the United States and foreign markets the additional tests, devices and therapeutics in its pipeline in a timely and cost effective manner, and other risks detailed from time to time in Atossa''s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.
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Datum: 05.12.2014 - 07:00 Uhr
Sprache: Deutsch
News-ID 1323306
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