FDA 483 - One Way Drug, LLC - May 30, 2014

This FDA Form 483 document details observations made during an inspection, indicating several deficiencies in the facility's operations related to drug product manufacturing, particularly concerning sterile products.

**Violations and Observations:**

1. **Sterilization Process Validation:** Procedures intended to prevent microbiological contamination of sterile drug products lack adequate validation of the sterilization process. This suggests a potential risk of non-sterile products reaching the market. 2. **Microbiological Testing:** Each batch of drug product required to be free of objectionable microorganisms is not subjected to appropriate laboratory testing. This omission means the facility cannot confirm the absence of harmful microbes in its products. 3. **Container Sterilization and Pyrogen Removal:** Drug product containers were not sterilized and processed to remove pyrogenic properties, failing to ensure their suitability for intended use. This directly impacts product safety and quality. 4. **Stability Testing Program:** A written testing program designed to assess the stability characteristics of drug products is absent. Without this, the facility cannot determine or confirm the shelf-life and potency of its products over time. 5. **Cleaning and Sanitizing Procedures:** Written procedures for the use of cleaning and sanitizing agents, crucial for preventing contamination of equipment, components, drug product containers, and drug products, are lacking. This indicates a systemic gap in contamination control. 6. **Protective Apparel:** Protective apparel is not worn as necessary to protect drug products from contamination. This observation points to a failure