FDA 483 - Exela Pharma Sciences LLC - November 15, 2024

This FDA Form 483 details multiple observations from an inspection of a 503B Outsourcing Facility and Drug Manufacturer.

**Observation 1** notes inadequate investigation into unexplained discrepancies. Specifically, a media lot used for sterility testing of Sodium Acetate failed initial growth promotion, was retested twice, and passed without scientific justification. The investigation, QE-000487, attributed failures to human performance without specific identification of error. Other growth promotion media failures were inadequately investigated, lacking root cause analysis or CAPA. Conductivity out-of-specification (OOS) results for the water system were retested to passing without root cause analysis or CAPA, and the issue persisted through multiple retests and samples before resolution.

**Observation 2** indicates that quality control unit responsibilities and procedures were not fully followed. Sodium Bicarbonate Injection, USP lot (b)(4), was filled in Augusta facility areas tagged as "QA HOLD" due to pending EPA certification.

**Observation 3** identifies deficiencies in procedures to prevent microbiological contamination of sterile drug products. Disinfectant Efficacy Studies for sterile nitrile gloves lacked documented contact time and had a dilution error. Disinfectant efficacy against *Candida albicans* did not meet criteria for test surfaces. Leaks were observed in the (b)(4) water system and holding tank. Visible damage (a big crack) was found on the sterility (b)(4) used for sterility testing, despite