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Medical Devices / Inspections and Audits

FDA Warns Becton Dickinson for Potentially Contaminated Water, Environmental Conditions

Oct. 17, 2018

In a warning letter to Becton Dickinson Medical System, the FDA said the devicemaker must further document its corrections to problems with environmental conditions and its preventive measures against contamination.

The FDA inspected BD’s facility in Franklin, Wisconsin from May 16 through Aug. 1 and found it had used municipal tap water, which has been found to be a potential source of microbial contamination, in cleaning and disinfecting solutions.

In response, the company promised to discontinue its use of tap water, temporarily shut down manufacturing operations and permanently remove faucets and sinks from the janitor’s closet.

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