- Delivery Method:
- Via Email
Recipient NameJustin Y. Chen
- Chen Shwezin, Inc. dba Park Compounding Pharmacy
4333 Park Terrance Drive
Westlake Village, CA 91361
- Issuing Office:
- Division of Pharmaceutical Quality Operations IV
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.
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV