FDA Warns Drug Manufacturers of Recalls due to BCC Contamination

May 31, 2017

FDA reminds drug mfg. of ways to reduce risk of BBC contamination

On Monday, May 22nd, the FDA issued a warning for drug manufacturers regarding the contamination risk posed by Burkholderia cepacia complex (BCC).  According to FDA’s warning, “BCC and other water-borne opportunistic pathogens are among the contaminants that can be found in pharmaceutical water systems.”  As such, BCC contamination has been the cause of numerous recalls regarding non-sterile water-based drug products.

Exposure to BBC can increase a person’s risk of illness or infection, especially if the individual suffers from a compromised immune system.  Because of this, it is extremely important that BBC contamination be identified and corrected as soon as possible.  However, “BCC can survive or multiply in a variety of non-sterile and water-based products because it is resistant to certain preservatives and antimicrobial agents.”  Furthermore, detecting the bacteria is very difficult, often requiring the use of validated testing methods that consider the unique characteristics of different strains of BBC.

In an attempt to reduce the occurrence of BBC contamination, FDA’s warning provides a number of reminders and recommendations for drug makers consider during the manufacturing process.  For details on FDA’s recommendations, view the Agency’s recent announcement.

FDA is asking individuals who experience adverse events or quality problems while using any non-sterile water-based drug product to submit a report to the MedWatch Adverse Event Reporting program.  Adverse events may be reported in the following ways:

  1. Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
  2. Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Do you manufacture a non-sterile water-based drug product or any other FDA-regulated product? Our quality & compliance group can help ensure that your manufacturing processes are compliant with all FDA regulations and requirements.  To learn more about our services and capabilities, contact us today.


October 27, 2015

House Committee Releases Draft Discussion Bill Regarding FDA's Regulations of In Vitro Clinical Testing

On Tuesday, November 17, 2015, the House of Representatives’ Energy & Commerce Committee will hold a hearing entitled, “Examining the Regulation of Diagnostic Tests and Laboratory Operations.” The...

August 9, 2016

FDA Issues Warning Letter to Chinese API Manufacturer After Lying to the Agency During Inspection

Late last month, FDA released a warning letter that had been sent to Xiamen Pharmaceutical Co., Ltd., outlining a number of “significant deviations from current good manufacturing practice (CGMP) for...

October 22, 2015

FDA Provides Recommendations on Injectable Drug Dose Labeling

On October 21, 2015, FDA released a draft guidance entitled “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose,...