FDA 483 - Fagron Compounding Services - March 24, 2022

Fagron Compounding Services in Wichita, KS, an outsourcing facility, was cited for multiple significant deficiencies during an FDA inspection. Observations included inadequate cleaning and disinfection in aseptic processing areas, lack of written procedures for production controls and in-process testing, and failure to test preservative content in multi-dose injectable products. Additionally, the firm was found to be compounding drug products using bulk substances not permitted under sections 503B and 506E of the FD&C Act.