A California drug compounding pharmacy has been cited by the U.S. Food and Drug Administration for unsanitary conditions in a facility producing sterile drugs.
Cited by the FDA today was Park Compounding, also known as Chen Shwezin located in California. Records show Park Compounding is currently licensed in Tennessee and Indiana.
The FDA notice called on health care providers to halt the use of any unused sterile drugs shipped by the firm.
According to the FDA, Park Compounding agreed to halt the production of sterile drugs but refused to order a recall of its shipped products.
The FDA reported finding poor sterile production practices at the company facilities. The agency reported that it has not received any notices of adverse effects by patients treated with sterile drugs from the company.
The report from an FDA inspection completed in September cited a lack of pest control, brownish staining on floors, walls and other surfaces, peeling paint and failure to conduct required environmental monitoring.
FDA records show Park did recall a lot of testosterone in 2013 after questions were raised about the validity of its sterilization testing.
AUDIENCE: Pharmacy, Compounding, Nursing, Risk Manager
ISSUE: During 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.
BACKGROUND: On September 29, 2015, FDA recommended that Park Compounding Pharmacy cease sterile operations until adequate corrections are made at its facility, and recall all of its non-expired sterile drug products. On September 30, 2015, Park Compounding Pharmacy informed FDA that it has agreed to cease sterile operations, but the company has refused to recall its products.
To date, FDA is not aware of any adverse events associated with the use of products from Park Compounding Pharmacy. Patients who have received drug products produced by Park Compounding Pharmacy and have concerns should contact their health care professional.
RECOMMENDATION: Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from Park Compounding Pharmacy, and not administer them to patients.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178