Personal-care-product giant Johnson & Johnson (J&J) was recently on the receiving end of a scathing letter from the U.S. Food and Drug Administration about faulty insulin pumps. The FDA reportedly questioned why J&J’s Animas unit continued to make and sell to consumers a certain insulin pump even after knowing that design problems to the keypad had caused product malfunctions.
The pumps in question are the 2020 and the One Touch Ping.
In its Dec. 27 letter, the agency apparently warned J&J that an inadequate response to the defective medical devices could bring fines or make J&J ineligible for federal contracts. The letter also requested information about internal quality oversight. J&J had 15 days to respond to the charges.
According to the FDA, J&J had started an internal investigation in April. The agency further faulted the company for reporting injuries related to pump use too slowly, and for not having a system in place for gathering information about problems outside the U.S.
J&J has been heavily sanctioned by the FDA over the past couple of years for faulty medical products. For example, the company had to recall “dozens” of nonprescription medications; it sold defective hip replacements; and the FDA stepped in to increase supervision of some of J&J’s manufacturing operations.
Publicly J&J has committed to regulatory compliance and high quality. Apparently, for the pump in question, the company has changed the design feature of concern, worked to assess associated danger and risk, and switched to a new supplier.
Source: Bloomberg, “J&J Sold Insulin Pumps After Learning of Defects, FDA Says,” Alex Nussbaum, Jan. 10, 2012.