FDA 483 - Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy - July 20, 2017

During an FDA inspection from July 13-20, 2017, Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy, a producer of sterile and non-sterile drug products in Fort Myers, FL, was cited for nine observations, many of which were repeat findings.

Key violations include: 1. **Aseptic Deficiencies (Repeat Observation):** Personnel failed to sanitize gloved hands, touched workstation surfaces, had exposed skin inside the laminar flow hood (ISO 5), and cleaned improperly. Media fills were deficient, not simulating stressful conditions, sterilizing potential growth, or including growth promotion. 2. **Environmental Monitoring Deficiencies (Repeat Observation):** Fungus (Chaetomium spp., Alternaria spp.) was detected in ISO 7 areas without documented corrective measures. Air sampling was not performed during dynamic conditions, and continuous air pressure differential monitoring was absent, with out-of-limit readings uncorrected. Personnel monitoring (e.g., fingertip sampling, gowning material sampling) was inadequate and not conducted during operations. 3. **Sterilization Process Validation (Repeat Observation):** Sterilization processes for equipment (e.g., [redacted] for glassware, [redacted] for stir bars/vial stoppers) were not validated, lacking written calibration procedures or documentation like temperature mapping. 4. **Contamination Prevention:** Personnel failed to sterilize a vial crimper or