Our facilities are registered with the United States Food and Drug Administration, the Michigan State Board of Pharmacy, the European Union (E.U.), and GDUFA Finished Drug Facility.

We certify that the methods, facilities and controls used in packaging drug product are in compliance with all applicable requirements of the Food Drug and Cosmetic Act, specifically Title 21 parts 210 and 211 of the Code of Federal Regulations for Good manufacturing Practices, and with all local and State regulations.

Under Section 306 (a) (2) and (b) (1) we also certify that we have not and will not use, in any capacity, the services of any person debarred under section 306 or the Federal Food Drug and Cosmetic Act.