The FDA has hit Becton Dickinson (BD) with a warning letter over unauthorized changes to devices and other regulatory violations. Inspectors identified a slew of violations at the BD site in New Jersey but have allowed the blood collection tubes at the center of the investigation to remain on the market.
BD found itself in the FDA’s crosshairs last year after Magellan Diagnostics fingered it as the possible cause of certain inaccurate test results. Magellan alleged the rubber stoppers of BD blood collection tubes could be responsible for the inaccurate lead test results that led to some of its products being recalled.
The FDA followed up on these allegations by inspecting a BD facility. Inspectors were unable to find evidence showing the use of BD collection tubes adversely affects blood test results. But they did find numerous regulatory failings that have landed BD in hot water.
“Our inspection showed that BD violated the law by making a significant change to certain devices the company manufactures without notifying the FDA and failing to follow good manufacturing practice requirements,” Donald St. Pierre, acting director of FDA’s Office of In Vitro Diagnostics and Radiological Health, said in a statement.
The significant change referred to by St. Pierre affected the formulation of the rubber stoppers used in BD Vacutainer K2EDTA tubes. In its warning letter, the FDA said the changes “could significantly affect the safety or effectiveness of the devices” and as such necessitated a 510(k) filing. BD made the changes in 2013 without notifying the FDA. And, in the inspectors’ view, it did so without adequately assessing the effect of its actions on the clinical performance of the device.
That led the FDA to issue a 483 following the inspection last summer. BD has since sent four sets of responses to the FDA, the most recent of which is dated Jan. 5, but failed to stop the agency hitting it with a warning letter on Thursday.
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The nearly 4,000-word warning letter shows that problems found by the FDA spiraled out from the tubes themselves to encompass multiple aspects of BD’s operation. For example, the FDA learned Magellan complained to BD about the results it generated when using Vacutainer tubes in 2015. The FDA said BD failed to investigate the complaint. Inspectors also took BD to task over its handling of a 2013 complaint related to the use of its tubes with Abbott’s i-STAT portable clinical analyzer.
Analysis of the handling of the Magellan complaint led the FDA to add another bullet point to its list of violations. The bullet point covers the regulatory consequences of BD’s failure to establish written procedures for complaint documenting and reporting software. Elizabeth Gaipa, BD’s worldwide VP of quality management, disclosed that shortcoming to the FDA during the inspection.
BD has until the start of February to inform the FDA of the specific steps it is taking to address all of the violations discussed in the warning letter.