US FDA warns liquid drug firms to test for Burkholderia cepacia
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.
Recalls
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.
