FDA Publishes Warning Letter To OraSure For Lack Of Documentation
OraSure Technologies recently sent a letter to the FDA in response to a warning letter their subsidiary, DNA Genotek, received in December 2013. After an inspection conducted at the company’s facilities located in Ottawa, Canada in September 2013, the FDA issued a Form 483 to DNA Genotek in response to non-satisfactory observations. DNA Genotek is OraSure’s molecular collection subsidiary.
OraSure’s letter has not yet been published but the FDA published their initial warning letter on their website on January 6, 2014. According to the warning letter, the FDA is requesting additional documentation for the company’s ORAcollect OC-100 collection device, in regards to product acceptance testing. This product mentioned in the letter is a swab-like sample collecting product that holds a small place in OraSure’s sales reports, having only accounted for 0.05% of 2013 annual sales.
The warning letter also states that some of DNA Genotek’s collection products are considered by the FDA to be devices because they are used to diagnose diseases under section 201(h) of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. § 321(h). However, the devices are not being documented according to the FDA’s requirements in terms of manufacturing practice, packaging, storage or installation.
In addition, the letter states that the company does not have a premarket approval application 510(k) for the collection device. The FDA warning letter addresses DNA Genotek’s lack of sufficient documentation regarding the company’s product design and development, specifically their OrageneDx collection product. OrageneDx, unlike the ORAcollection OC-100, is used in commercial applications.
Douglas A. Michels, president and CEO of OraSure Technologies, stated "We take this letter from the FDA very seriously and we are working closely with the agency to ensure we fully address their concerns and observations." He went on to say, “We are committed to providing the highest quality products to our customers and to continuously enhancing our systems and processes."
According to Michels, DNA Genotek is working to address the FDA’s concerns as stated in the Form 483 observations, but will continue to sell and market its products while doing so.