University Rx Gets Warning Letter Over Unapproved Product
University Rx Specialties has been hit with a warning letter after investigators discovered issues relating to misbranded and unapproved drug products.
Inspectors noted records showing that the firm produced domperidone drug products. Domperidone is not the subject of an applicable U.S. Pharmacopeia or National Formulary monograph, is not a component of an FDA-approved human drug product, and does not appear on a list developed by the HHS secretary.
In addition, FDA inspectors also observed that drug products in their facility that were intended or expected to be sterile were prepared, packed, or held under insanitary conditions.