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  5. Chen Shwezin, Inc. dba Park Compounding Pharmacy - 496320 - 07/20/2020
  1. Warning Letters

CLOSEOUT LETTER

Chen Shwezin, Inc. dba Park Compounding Pharmacy MARCS-CMS 496320 —

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

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