FDA 483 - Sircle Laboratories, L.L.C. - March 19, 2019

An FDA inspection of Circle Laboratories, L.L.C. in Madison, MS, an Own Label Distributor, revealed significant deficiencies in quality control, complaint handling, and labeling procedures. The firm failed to establish quality agreements with contract manufacturers, did not properly document and investigate drug product complaints, and lacked adequate written procedures for the review and approval of drug product labels. This inspection identified a repeat observation regarding the lack of written procedures for labeling.