US FDA issues alert for sterile products made by Californian compounder
The alert comes less than a month after the US Food and Drug Administration (FDA) inspected the facility in Westlake Village - operated by the firm Chen Shwezin under the name Park Compounding Pharmacy – and warns health care professionals and patients not to use allegedly sterile drug products made there.
“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 Agency said in a statement.
In all, the Agency cited ten observations during the inspection, including a lack of procedures in place to prevent the microbiological contamination of drug products purporting to be sterile, and a lack of monitoring systems in aseptic areas.
It was also observed that an area where containers and closures were sterilised doubled up as a break and snack room for the firm’s employees.
Last week, the FDA recommended that Park Compounding Pharmacy cease sterile operations until adequate corrections are made at its facility, and recall all of non-expired sterile drug products. While the firm has stopped production, the Agency says it refuses to issue a recall.
A deadly meningitis breakout in 2012 stemming from a Massachusetts-based compounding pharmacy led to greater regulatory scrutiny of such companies and resulted in the option for compounders to register as an outsourcing facility in the 2013 Drug Quality and Security Act (DQSA).
The latest guidance for compound pharmacies wishing to register as an outsourcing facility was issued in August.
Park Compounding Pharmacy is not registered as such a facility, according to the FDA’s website.
