Pine Pharmacy and Home Care Products Center, Inc.

CLOSEOUT LETTER Pine Pharmacy and Home Care Products Center, Inc. MARCS-CMS 435704 — April 25, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Next Day Air Reference #: NYK-2015-24 Product: Drugs Recipient: Recipient Name Alfonse Muto, Sr. Recipient Title Owner Pine Pharmacy and Home Care Products Center, Inc. 5110 Main Street Williamsville , NY 14221 United States Issuing Office: Center for Drug Evaluation and Research United States (973) 331-4900 Dear Mr. Muto: The U.S. Food and Drug Administration (FDA) has completed an evaluation of (your/your firm’s) corrective actions in response to our warning letter (ref: NYK-2015-24), dated February 13, 2015. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter. You are expected to take all necessary steps to assure 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/District Director Office of Pharmaceutical Quality Operations - Division I New Jersey District Office Content current as of: 06/03/2019 Regulated Product(s) Drugs