Eugia Pharma Specialities Limited — FDA Warning Letter Findings

Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188). You failed to ensure records for equipment cleaning, disinfection, and sterilization are complete and accurate. For example, operators documented in production records for three batches of sterile injectable drug products that the stopper (b)(4) bowl and cap (b)(4) bowl for your (b)(4) were…

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). You failed to conduct adequate investigations and to implement effective corrective actions and preventive actions (CAPA) to prevent recurrence of vial breakage during manufacturing of sterile injectable drug products. For example, your investigation…

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). You failed to ensure your operators adequately follow your written procedures for aseptic behaviors and interventions performed for manufacturing numerous sterile injectable drug products on multiple (b)(4)…