FDA EIR - Exela Pharma Sciences LLC - December 19, 2018

An FDA compliance follow-up inspection of Exela Pharma Sciences LLC, a manufacturer of sterile small volume parenteral drug products, was conducted from December 12-19, 2018. The inspection evaluated the company's adherence to Current Good Manufacturing Practices (cGMP) under compliance program 7356.002A, focusing on quality, materials, and production systems, and verifying corrective actions from a previous 2017 inspection.

While the prior inspection resulted in a Form FDA-483 citing deficiencies such as untimely deviation investigations and inadequate identity/integrity testing for manufacturing gases, this current inspection did not result in a new FDA-483 issuance. However, several critical observations were discussed with management for immediate improvement.

Key issues raised included an inoperable HEPA filter in a sterile fill suite for over a year without proper evaluation, improperly labeled non-sterile solution for tools used in aseptic operations, and a lack of continuous monitoring for positive airflow in a critical cleanroom. Concerns also involved a physical gap in a cleanroom material transfer window, undocumented operational challenges for an automated visual inspection machine, and insufficient procedures for the storage and labeling of in-process materials. Furthermore, a raw material had remained in quarantine for over a year due to delayed testing.

Management acknowledged these concerns and committed to addressing them, including repairing/replacing the HEPA filter, ensuring proper labeling and training, implementing continuous airflow monitoring, documenting equipment challenges, formalizing WIP procedures, and discarding the compromised raw material. The agency will further evaluate these discussions for final compliance determination.