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# BCC May Contaminate Some Water-Based Drugs: FDA
- URL: https://www.fdaweb.com/bcc-may-contaminate-some-water-based-drugs-fda/
- Published: 2021-07-08T12:00:00.000Z
- Updated: 2026-09-14T17:05:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149663

FDA says manufacturers of non-sterile water-based drug products should be aware that *Burkholderia cepacia* complex (BCC) continues to pose a contamination risk. An agency [notice](https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-drug-manufacturers-burkholderia-cepacia-complex-poses-contamination-risk-non-sterile?ref=fdaweb.com) says BCC is a significant pharmaceutical contaminant that has been linked to multiple instances of opportunistic infections.

“Inadequate design, control, or maintenance of pharmaceutical water systems have led to contamination with BCC and other water-borne opportunistic pathogens,” the agency says…. “It is essential that manufacturing facilities, equipment, and processes are designed to prevent contamination and strict sanitary standards are continually followed. There is a long history of product recalls due to BCC contamination traced back to deviations from current good manufacturing practice requirements.”