APS BioGroup, Inc

CLOSEOUT LETTER APS BioGroup, Inc April 05, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: APS BioGroup, Inc United States Issuing Office: United States U.S. Food & Drug Administration PO Box 25087 Denver, CO 80225 April 5, 2018 WARNING LETTER CLOSE-OUT VIA UPS overnight Mr. George Stagnitti, President & CEO APS Biogroup, Inc. 2235 South Central Ave. Phoenix, AZ 85004-2909 Dear Mr. Stagnitti: The Food and Drug Administration has completed an evaluation of APS Biogroup's corrective actions in response to our Warning Letter HAF4W(DEN)-17-10-WL dated July 6, 2017. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ LaTonya M. Mitchell District Director, FDA Denver District Program Division Director Office of Human and Animal Foods - Division IV West Content current as of: 04/24/2018 Regulated Product(s) Drugs