FDA 483 - Medline Industries, Inc. - January 16, 2025

During an inspection from December 4-8, 2023, the FDA identified significant deficiencies at XELLA an Apotex Company, a drug manufacturer located in Miami, FL. The observations, detailed in an FDA Form 483, indicate failures to adhere to current Good Manufacturing Practice (cGMP) regulations.

Key issues include inadequate investigation of Out-of-Specification (OOS) results for drug products, with repeated failures to identify definitive root causes, provide sufficient justification for invalidating results, or implement effective corrective and preventive actions. The firm also demonstrated significant lapses in aseptic processing controls. These include personnel using non-sterile gowns and shoe covers in Grade A/B aseptic suites and improper sterile gloving practices. Procedures to prevent microbiological contamination were found deficient, lacking scientific justification for sterilized equipment hold times, and media fill simulations failing to represent worst-case conditions (e.g., batch size, personnel, shift changes). Furthermore, the environmental monitoring system for aseptic areas was inadequate, with air samplers not strategically located at critical product exposure sites. Finally, the firm failed to consistently follow written production and process control procedures, specifically regarding the documentation of interventions during aseptic filling operations, impacting the accuracy of media fill simulations.

XELLA is required to address these observations promptly by implementing robust corrective actions and providing a comprehensive response to the FDA.