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FDA Issues Warning Letter to Becton Dickinson Over Facility Violations

This article has been updated to include a response from Becton Dickinson.

NEW YORK (360DX) – The US Food and Drug Administration today issued a warning letter to Becton Dickinson, outlining a number of violations of federal law related to the company's Vacutainer blood collection tubes, including changes it made to the tubes and its failure to investigate complaints about their performance.

BD said it has taken steps to address the FDA's concerns and will provide a response to the agency's letter within the required timeframe.

Last year, the FDA alerted people who had been tested for lead poisoning with Magellan Diagnostics' lead testing systems that they should be retested due to the possibility of inaccurate results. Magellan had said the faulty results could be related to BD blood collection tubes used with the tests.

As part of an ongoing investigation into the issue, the FDA conducted an inspection of BD's New Jersey facility that preliminarily indicated BD's tubes were not the cause of the inaccurate lead poisoning tests, but uncovered a number of other problems.

According to the FDA's warning letter, that inspection revealed evidence of numerous violations including BD's failure to properly test the clinical performance of newly formulated rubber stoppers used in some BD Vacutainer tubes or notify the agency of the change made to the stoppers.

Among the FDA's other findings were that BD failed to comply with the good manufacturing practice requirements of the agency's Quality System regulation for certain Vacutainer tubes, and that the company did not adequately review, evaluate, and investigate complaints from Magellan regarding the inaccurate lead poisoning test results.

The FDA said that BD has until Feb. 1 to respond to its letter with specific steps it has taken to address the violations and prevent them from recurring. "If the company fails to promptly correct these violations, the FDA may take additional action, such as seizure, injunction, and civil money penalties," the agency said.

Richard Byrd, worldwide president of BD Preanalytical Systems, said in a statement that the company takes any potential issue with its products very seriously and is cooperating fully with FDA.

"After the FDA inspection in July, we took prompt action that we believed fully addressed the agency's inspectional observations," he added. "We are carefully reviewing the agency's feedback outlined in yesterday's letter with the highest sense of urgency, and we will provide a full response to FDA on or before their Feb. 1 deadline."