Drug Products Intended to be Sterile by Chen Shwezin Inc., dba Park Compounding Pharmacy: Lack of Sterility Assurance

During the FDA’s recent inspection of Park Compounding Pharmacy’s facility, FDA investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about the company’s ability to assure the sterility of drug products that it produced. The FDA is alerting health care professionals and patients not to use drug products intended to be sterile made and distributed by Chen Shwezin Inc., doing business as Park Compounding Pharmacy, in Westlake Village, Calif. [10/5/15]

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