FDA Warning Letter (Better SELL this junk right now, FDA is going to shut them down)
On May 28, 2015, the Company received a warning letter dated May 27, 2015 (the “Warning Letter”), from the U.S. Food and Drug Administration (the “FDA”) resulting from an inspection of the Company’s facility in River Edge, New Jersey by the FDA’s New Jersey District Office that occurred during October 2014. The Warning Letter alleges deficiencies relating to the Company’s compliance with the Quality System regulation and the Medical Device Reporting regulation. The Company takes the matters identified in the Warning Letter seriously and is in the process of evaluating the corrective actions required to address the matters raised in the Warning Letter. The Company also is in the process of preparing a response to the Warning Letter and intends to respond fully to the issues raised by the FDA within 15 business days as requested by the FDA, and to work diligently and expeditiously to resolve the issues raised by the FDA. The Warning Letter does not restrict the manufacture, production or shipment of any of the Company’s products, nor require the withdrawal of any product from the marketplace. However, failure to promptly address the issues raised in the Warning Letter to the FDA’s satisfaction or to comply with U.S. medical device regulatory requirements in general could result in regulatory action being initiated by the FDA. These actions could include, among other things, delays in approval of any FDA applications, product seizures, injunctions and civil monetary penalties. Any such actions could disrupt our ongoing business and operations and potentially have a material adverse impact on our financial condition and operating results. A copy of the Warning Letter is attached hereto as Exhibit 99.1.
Everything I say and write is my opinion and my opinion only. Do your own due diligence when investing
