483
Sofie Co dba SofieSofie Co dba Sofie – FDA 483, Dec 3, 2018
Record Details
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.
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ID · 3465ef16-1bcf-4612-afe1-248b0baa6812
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