Custom Compounding Center – FDA 483, Apr 9, 2015

This FDA Form 483 document outlines observations made during an inspection of a pharmaceutical manufacturing facility. The inspection revealed several deficiencies related to the production of sterile drug products and overall quality control.

A significant finding was the absence of validation for the sterilization process within the procedures designed to prevent microbiological contamination of sterile drug products. This indicates a critical gap in ensuring product sterility.

Furthermore, the aseptic processing areas were found to be deficient concerning their air supply, specifically lacking high-efficiency particulate air (HEPA) filters under positive pressure. This deficiency compromises the controlled environment necessary for sterile manufacturing.

The facility also lacked adequate separate or defined areas and control systems, which are necessary to prevent contamination or mix-ups of drug products. This suggests a broader issue with facility layout and operational controls.

Finally, it was observed that protective apparel was not worn as necessary to protect drug products from contamination, indicating a lapse in personnel hygiene and gowning procedures critical for maintaining product integrity in a sterile environment. These observations collectively point to significant issues in the facility's quality system and manufacturing practices for sterile drug products.