Hieber's Pharmacy

CLOSEOUT LETTER Hieber's Pharmacy MARCS-CMS 480933 — May 01, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: 15-PHI-20 Product: Drugs Recipient: Recipient Name Ms. Rosemary E. Mihalko, RPh Recipient Title Owner Hieber's Pharmacy 3500 5th Avenue Pittsburgh , PA 15213-3337 United States Issuing Office: Division of Pharmaceutical Quality Operations I United States (973) 331-4900 Dear Ms. Mihalko: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #15-PHI-20, dated September 20, 2015, and our warning letter #542220, dated December 5, 2017. Based on our evaluation, it appears that you have adequately addressed the violations contained in these warning letters. You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Diana Amador-Toro Program Division Director Office of Pharmaceutical Quality Operations Division I/New Jersey District Content current as of: 05/21/2020 Regulated Product(s) Drugs