# FDA 483 - Mark Cuban Cost Plus Manufacturing and Compounding LLC - September 06, 2024

Source: https://www.keypedia.com/records/483/mark-cuban-cost-plus-manufacturing-and-compounding-llc/8d077c61-a388-40e0-9c88-17076e500825

> FDA 483 for Mark Cuban Cost Plus Manufacturing and Compounding LLC on September 06, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mark Cuban Cost Plus Manufacturing and Compounding LLC
- Inspection Date: 2024-09-06
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

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Company: https://www.keypedia.com/companies/mark-cuban-cost-plus-manufacturing-and-compounding-llc/eef9f58a-1e37-41d6-be46-57cfe8ca2f03

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c