FDA 483 - Sofie Co dba Sofie - December 03, 2018

Sofie Co dba Sofie in Sterling, VA, a PET drug manufacturer, received a Form 483 with three observations. The inspection revealed inadequate facilities for contamination prevention, failure to submit required NDA-Field Alert Reports for distributed drug products, and non-adherence to written quality assurance procedures regarding annual product reviews. These issues indicate potential risks to product quality and regulatory non-compliance.