FDA 483 - Advanced Infusion Solutions - October 27, 2015

This FDA Form 483 document outlines observations made during an inspection of a facility involved in the manufacturing of drug products, specifically those purporting to be sterile. The inspection revealed deficiencies in the aseptic processing areas and the procedures designed to prevent microbiological contamination.

Key observations include: 1. **Deficient Environmental Monitoring System:** The system for monitoring environmental conditions within the aseptic processing areas was found to be deficient. This indicates a potential lack of adequate control over the environment where sterile products are handled, increasing the risk of contamination. 2. **Inadequate Procedures for Microbiological Contamination Prevention:** Procedures intended to prevent microbiological contamination of sterile drug products were either not established or not consistently followed. This suggests a systemic issue in ensuring product sterility throughout the manufacturing process. 3. **Improper Use of Protective Apparel:** Protective apparel was not worn as necessary to protect drug products from contamination. This directly impacts the integrity of the sterile environment and poses a significant risk of introducing contaminants from personnel into the product.

These observations highlight critical issues within the facility's quality system and manufacturing practices related to aseptic processing and sterility assurance. The deficiencies could have significant business and operational implications, potentially requiring remediation actions to ensure compliance with regulatory requirements for sterile drug product manufacturing.