Improve compliance :
CDC Infection Control Guidelines – emphasize single-use devices to prevent cross-contamination. Centers for Disease Control and Prevention. Guidelines for Infection Control in Health- Care Facilities, 2021.
USP <797> and <800> – require single-use vials/containers whenever possible to reduce microbial risk.
FDA Intranasal Medication Administration Guidelines – emphasize reliable spray patterns and dose reproducibility for safety and efficacy.
Our device has not been recalled due to plume inconsistencies. U.S. Food and Drug Administration. Enforcement Reports and Recalls related to intranasal atomization devices. FDA, 2017–2019
503B Outsourcing with Bennett Pharma
Bennett Pharmaceuticals is a federally registered 503B outsourcing facility—an essential partner capable of manufacturing at scale under FDA oversight with full cGMP compliance.
With Bennett as a 503B outsourcing partner, our parents gain not only innovative drug-delivery systems but also a secure, compliant, and strategically aligned partner dedicated to improving access to needed medications.
