The FDA issued a warning letter to Becton Dickinson for distributing adulterated and misbranded devices, among other significant CGMP violations.
The agency’s inspection of the device manufacturer’s Franklin Lakes, New Jersey facility revealed that the firm did not have an approved application for premarket approval for its BD Vacutainer K2EDTA Tubes product, and did not notify the agency of its intent to commercially distribute the product after making significant changes to its rubber stoppers.
Tests the firm ran to predict the impact of the modifications on the product were not deemed accurate and reliable and did not include clinical testing. The inspector noted that the modifications could have a large impact on the product’s safety and effectiveness, as well as on other products, and warranted submissions of new premarket notifications.
The inspection also found numerous failures to meet CGMP requirements. In one instance, the firm did not have adequate procedures in place to manage complaints, neglecting to document a complaint about negative bias in blood test results collected in Vacutainer tubes. In addition, the firm did not identify an inquiry call log as a source of data for complaint review.