FDA EIR - Exela Pharma Sciences LLC - October 22, 2019

An FDA pre-approval inspection of Exela Pharma Sciences LLC in Lenoir, NC, was conducted from October 15-22, 2019, under Compliance Program 7346.832. The inspection aimed to assess readiness for commercial manufacturing of several sterile small volume parenteral and terminally sterilized drug products, particularly at their new Augusta manufacturing site. This inspection also followed up on a previous March 2019 inspection that resulted in a ten-item FDA 483. Previous violations included issues with data integrity for laboratory controls and critical equipment, inadequate environmental monitoring, use of non-cleanable equipment, deficiencies in batch records, material control, storage, facility space, equipment logs, and employee training. During the October 2019 inspection, Exela Pharma Sciences demonstrated that many corrections to the prior 483 observations were implemented and verified. Consequently, no new FDA Form 483, Inspectional Observations, was issued. However, the inspection concluded with five verbal observations requiring action. These included concerns regarding unpaginated batch record review forms, cleaning residue on manufacturing equipment at the Augusta facility, the need for more scientifically sound cleaning validation calculations for new product introductions, inconsistent operation and lack of qualification details for warehouse ceiling fans, and an unsealed opening observed in a Michelle facility filling operation. The company acknowledged these observations and committed to implementing corrective actions. They also confirmed ongoing efforts, supported by external consultants, to address previous findings and enhance manufacturing capabilities.