FDA Closes Inspections on Atossa Genetics

Seattle-based Atossa Genetics has received establishment inspection reports officially closing FDA inspections from 2012 and 2014, the company said Friday.

Over the past 18 months, the company worked to ensure that all observations noted during the inspections were quickly addressed, said CEO and President Steven Quay. “We will continue to devote significant resources to ensure that our regulatory compliance meets current standards worldwide with respect to our business," he added.

In October 2013, the company voluntarily recalled its ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test, due to concerns raised in a February 2013 FDA warning letter. The concerns related to the products’ instructions for use, promotional claims and lack of FDA clearance for alterations in the specimen collection process. The agency said the modified process could lead to false results.

Atossa makes tests for breast cancer and is currently developing a microcatheter for delivery of drug therapies directly into the milk ducts. — Kellen Owings

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