Earlier this week FDA posted two 483 documents on its website related to several problems it saw during inspections of Theranos’ facility. Following these now very-public issues related to design validation, complaint handling and shipment of “uncleared” product in interstate commerce, Theranos has issued a statement on its website.
- FDA issued two Form 483s. Theranos stated: “None of these observations were specific to Theranos’ analytical devices, software, or chemistries, or the manufacturing infrastructure for Theranos’ analytical devices or chemistries. All observations from this inspection pertained to quality systems associated with the use of one of our Nanotainer™ tubes under the CLIA lab quality framework instead of the FDA quality framework.”
- FDA observed that Theranos’ Nanotainer tubes were uncleared and being shipped in interstate commerce. Theranos stated: “In our discussions with FDA, we determined that it was appropriate to temporarily pause use of the Nanotainer tubes that had been operating under the CLIA lab quality systems and are currently waiting for clearance… We are in close contact with FDA in this process and are confident that we will achieve clearance of the Nanotainer tubes.”
And finally, a Form 483 is not a warning letter, stressed Theranos. “These observations are, by their very nature, not final agency determinations. Contrary to what we’ve seen published, no warning letter was or has been discussed or mentioned.”
Review the full statement by Theranos.