Animas, a Johnson & Johnson company, knew of malfunctions in its insulin pumps, but continued selling those models of insulin pumps anyway, according to an FDA warning letter sent to the company Dec. 27 and released to the public Jan. 10.
The FDA criticized Animas for not adequately explaining “why your firm continued to manufacture insulin pumps” after they “had known failures.”
In the letter, the FDA said Animas failed to explain “why it was acceptable for your firm to continue to use” remaining pumps “with known failure modes.”
Failures of the Animas’ OneTouch Ping and 2020 pumps triggered a company investigation that started in April 2010, according to the FDA’s letter.
The insulin pump defect was in the device’s keypad, according to Animas spokesperson Caroline Pavis, in an interview with a Bloomberg reporter. The publicly release version of the FDA warning letter did not reveal the exact nature of the defects, as some text was deleted from the original sent to Animas.
The FDA warning letter cautioned the company that fines could follow and the company could be locked out of federal contracts. The agency gave Animas 15 days to respond.
Johnson & Johnson has been the subject of several safety recalls and FDA warnings over the last two years.