FDA 483 - LEESAR, INC - August 08, 2014

This FDA Form 483 was issued to LeeSar, INC, an Outsourcing Facility located at 2727 Winkler Ave, Fort Myers, FL, following an inspection from August 4-8, 2014. The inspection identified six observations related to aseptic processing, environmental control, personnel practices, sterilization validation, cleaning, and quality control.

**Key Observations:**

1. **Deficient Aseptic Processing Areas (Equipment Control):** * The pressure differential gauge between the ISO 7 clean room and ISO 8 ante room is not monitored daily during production. * Airflow studies were not performed under static or dynamic conditions to verify that processing equipment does not impede unidirectional airflow in the ISO 5 classified area.

2. **Deficient Aseptic Processing Areas (Environmental Monitoring):** * The environmental monitoring program lacks daily surface or viable air sampling in ISO 5 classified areas during production. * It also lacks monitoring of non-viable particles in ISO 5 areas under dynamic conditions and personnel monitoring.

3. **Inappropriate Personnel Clothing:** * Non-sterile gowns are used during aseptic operations, including loading components and vials into the ISO 5 IV classified area. * Gowns are reused throughout the day.

4. **Lack of Sterilization Process Validation:** * Procedures to prevent microbiological contamination do not include validation