Aug. 25 at 5:33 AM
$UNCY The FDA does not announce future re-audit dates ahead of time to prevent companies from altering normal daily operational compliance. And, before a schedule is set, the afflicted third party supplier has to provide sufficient evidence (by paper work) to make the FDA believe that 1) all deficiencies are solved and 2) an on site inspection is appropriate. UNCY itself is not involved here in this back-and-forth between FDA and the third party. And, what is outstanding here, we have to do with a nano-formulation of a drug, thus, quite a lot of things to handle which do not come along with the production of drugs where the challenges of nano are not in play. There are not much companies in US and overseas with the capabilities needed to manage nanoformulation.
