Abington Memorial Hospital, IRC

CLOSEOUT LETTER Abington Memorial Hospital, IRC MARCS-CMS 576854 — August 28, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: CBER-19-02 Product: Biologics Recipient: Recipient Name G. Chris Christensen III Recipient Title Chairman Abington Memorial Hospital, IRC 1200 Old York Road Abington , PA 19001 United States Issuing Office: Center for Biologics Evaluation and Research 10903 New Hampshire Avenue WO 71 RM 5128 Silver Spring , MD 20993 United States Dear Dr. Christensen: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter CBER-19-02 dated June 24, 2019. Based on our evaluation, it appears that you have addressed the violations 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 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/ Mary A. Malarkey, Director Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research CC: Lisa K. Buchanan, Director Division of Compliance Oversight Office of Human Research Protections 1101 Wootton Parkway, Suite 200 Rockville, Maryland 20852 Content current as of: 08/30/2019 Regulated Product(s) Biologics