FDA issued a Class II enforcement action. Affects Tango3 LLC. Reason: During an FDA inspection, the firm was notified of Quality System deficiencies, which included lack of procedures for de.
During an FDA inspection, the firm was notified of Quality System deficiencies, which included lack of procedures for design control and customized modifications that were either not reviewed or re...
Product was shipped to the following states: CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, NH, NJ, NM, OH, PA, RI, TX and VA.