CLOSEOUT LETTER

Abington Memorial Hospital, IRC MARCS-CMS 576854 — August 28, 2019

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