Mark Cuban Cost Plus Manufacturing and Compounding LLC – FDA 483, Sep 6, 2024

This FDA Form 483 details observations from an inspection of a drug manufacturing facility.

**Facility and Operations:** The facility manufactures sterile drug products, including Epinephrine Injection, USP 5mg/5mL (1mg/mL), and miglustat suspension. Operations involve ISO 7 and ISO 5 classified cleanroom areas for sampling, weighing, dispensing, formulation, and filling.

**Violations and Observations:**

1. **Microbiological Contamination Prevention:** * Sterile filling technicians did not adequately disinfect sterile gloves with sufficient frequency when moving between ISO 7 areas and performing tasks, contrary to procedure DAL-SOP-0227. * Poor technique was observed during sterile glove donning in ISO 5 prior to environmental monitoring strip preparation. * Procedure DAL-SOP-0237 for cleaning and disinfection of cleanroom areas failed to ensure sporicidal agent contact time for production equipment in the ISO 7 Formulation Room.

2. **Building Construction Suitability:** * The ISO 7 Filling Room (RM 034) has exposed sprinkler heads in the ceiling, preventing adequate cleaning and posing a contamination risk.

3. **Equipment Cleaning and Sanitization:** * Laptop and desktop computer keyboards used in ISO 7 cleanroom areas (Sampling/Weighing/Dispensing Room, Formulation Room, and Filling Room) were not cleaned and disinfected