FDA 483 - FillTech USA, LLC - December 19, 2025

FillTech USA, LLC, an OTC contract drug manufacturer in Rockwell, NC, was cited for multiple significant deficiencies during an FDA inspection. Observations included inadequate quality control unit procedures, incomplete annual product reviews, deficient equipment cleaning and maintenance, an inadequate water system, and a lack of proper temperature monitoring for stored materials. Several issues, such as water system inadequacy and temperature monitoring, were repeat observations from a previous inspection.