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# FDA Warns on Burkholderia Cepacia Contamination
- URL: https://www.fdaweb.com/fda-warns-on-burkholderia-cepacia-contamination/
- Published: 2017-05-22T12:00:00.000Z
- Updated: 2026-09-14T22:25:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138744

FDA is warning drug manufacturers of non-sterile, water-based drug products that there have been the subject of recent product recalls due to *Burkholderia cepacia* complex (BCC) contamination. “BCC and other water-borne opportunistic pathogens are among the contaminants that can be found in pharmaceutical water systems,” an agency [safety alert](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTcwNTIyLjczNjU2MDAxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE3MDUyMi43MzY1NjAwMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NDE3MjEyJmVtYWlsaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ1c2VyaWQ9ZGF2aWRAZmRhd2ViLmNvb&ref=fdaweb.com) says. “People exposed to BCC are at an increased risk for illness or infection, especially patients with compromised immune systems.”

Specifically, FDA is reminding drug manufacturers to:

- Establish procedures designed to prevent objectionable microorganism contamination of non-sterile drug products (e.g., procedures to assure adequate quality of incoming materials, sanitary design, equipment maintenance and cleaning, production and storage time limitations, and environmental monitoring).
- Use scientifically sound and appropriate acceptance criteria and test procedures to assure that drug product components and finished drug products conform to quality standards.

Provide appropriate drug product specifications (tests, methods, and acceptance criteria) in applications submitted to the FDA. In some cases, additional laboratory tests may be needed to determine whether products are suitable for release.