FDA 483 - Exela Pharma Sciences LLC - March 29, 2019

Exel B Pharma Sciences LLC, a sterile drug manufacturer in Lenoir, NC, received ten observations during an FDA inspection. The firm was cited for significant data integrity deficiencies in laboratory controls and equipment, inadequate environmental monitoring and cleaning in aseptic processing areas, and incomplete batch production records. Additional issues included lacking material identification procedures, improper product storage, insufficient facility space, poorly controlled equipment logs, and inadequate employee training.