The Food and Drug Administration is looking for answers as to why a unit of Johnson & Johnson continued to sell defective medical equipment after learning of malfunctions associated with it.
According to Bloomberg, One Touch Ping and 2020 pumps manufactured by J&J subsidiary Animas were found to have a defect in the keypads that required a partial redesign, as well as a switch to a different supplier.
However, after learning of the defect, the FDA uncovered that Animas continued to use the remaining pumps with known failure modes and sell them to medical providers.
Animas was also called out for not quickly reporting three incidents in which patients using the pumps were injured to the FDA. While two of the three cases eventually were found to result from user error, the FDA still cited Animas for lacking the proper procedures and not notifying officials within 30 days of learning of the incident.
The FDAs questions and concerns were noted in a warning letter that was dated December 27, 2011 and sent to Animas General Manager Kenneth J. Tompkins.