US FDA issues alert for sterile products made by Californian compounder

By Dan Stanton

- Last updated on GMT

US FDA issues alert for sterile products made by Cali compounder

Related tags Pharmacy Pharmacology

The US FDA has issued a product safety alert and recommended a compounding pharmacy cease manufacturing operations after observing unsanitary conditions at a Californian facility.

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​.

Related news

Show more

Related products

show more

Pulmonary Delivery of Orally Inhaled Therapeutics

Pulmonary Delivery of Orally Inhaled Therapeutics

Content provided by Catalent Pharma Solutions | 19-Oct-2023 | Business Advice

New classes and indications of orally inhaled therapeutics are rapidly expanding, with the development pipeline increasingly featuring both large and small...

Addressing Challenges with Clinical In-Use Testing

Addressing Challenges with Clinical In-Use Testing

Content provided by Lonza | 12-Oct-2023 | White Paper

Lonza Drug Product expert Léa Sorret PhD explores Clinical In-Use Testing of Biotherapeutics in this white paper. Léa shares her expertise and describes...

Manufacturing Drugs with Highly Potent APIs

Manufacturing Drugs with Highly Potent APIs

Content provided by Altasciences | 28-Sep-2023 | White Paper

In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs),...

Related suppliers

Follow us

Products

View more

Webinars