US FDA warns liquid drug firms to test for Burkholderia cepacia

By Gareth Macdonald

- Last updated on GMT


Related tags Pharmaceutical drug Microbiology

Burkholderia cepacia contamination is a risk for drug makers according to the US FDA, which says only rigorous testing can ensure the safety of non-sterile, water-based products.

The US regulator published the warning this week, reminding manufacturers Burkholderia’s resistance to antimicrobials combined with its ability to survive in factory water systems makes it a particular concern.

The FDA also said: “Detecting BCC bacteria is also a challenge and requires validated testing methods that take into consideration the unique characteristics of different BCC [Burkholderia cepacia complex] strains​.”

It advised manufacturers to establish testing microbiological procedures for materials – including water used in production – and to thoroughly investigate any out-of-spec results.


Burkholdia cepacia​ has been a concern in the US for several years.

Last year​ the US Centres for Disease Control (CDC) reported a surge in infections in several States.

The US Food and Drug Administration (FDA) later​ linked the outbreak to contaminated constipation remedies made by PharmaTech LLC​.

PharmaTech recalled​ products made at its facility in Davie, Florida last summer.

The US FDA also investigated Laxachem Organics Pvt. Ltd, an Indian active pharmaceutical ingredient supplier​ (API) that makes docusate sodium USP, the ingredient in the recalled products.

However, the agency later concluded​ Laxachem had not supplied PharmaTech and was not the source of the bacterial contamination.

In October​, a separate outbreak of Burkholderia cepacia infections was linked to contaminated prefilled saline flush syringes manufactured by Nurse Assist at it's facility in Haltom City, Texas.

The syringes were recalled​ later that month.

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