Chen Shwezin, Inc. dba Park Compounding Pharmacy

CLOSEOUT LETTER Chen Shwezin, Inc. dba Park Compounding Pharmacy MARCS-CMS 496320 — July 20, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Recipient: Recipient Name Justin Y. Chen Recipient Title Owner Chen Shwezin, Inc. dba Park Compounding Pharmacy 4333 Park Terrance Drive Suite 160 Westlake Village , CA 91361 United States Issuing Office: Division of Pharmaceutical Quality Operations IV United States 949-608-2900 Dear Mr. Chen: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL #20-17), dated March 15, 2017. We acknowledge that your firm no longer produces sterile drug products. 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 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/ CDR Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV Content current as of: 08/05/2020