The maker of many of the drug infusion pumps used in the U.S. has received a warning letter from the Food and Drug Administration over conditions at its manufacturing facility in Puerto Rico.
Hospira Inc. indicated that it received the warning letter recently in its quarterly filing with the Securities and Exchange Commission, according to a Reuters report. Hospira manufactures the Plum drug infusion pump, which it had to recall in February 2011 due to a problem with the medical device’s warning system.
Drug infusion pumps often feature an audible alarm to alert caregivers or drug recipients that there is a problem with the product. Malfunctions with a drug infusion pump could result in improper drug delivery, likely to result in an overdose or not enough of a drug being delivered.
The FDA was compelled to issue a warning to Hospira after inspectors representing the agency visited the company’s facility in La Aurora de Heredia, Costa Rica, in April. They found deficiencies with the operations there, problems they said likely caused the Plum alert system to fail. The FDA believes that since the recall of the Plum infusion pumps, the company has not taken any steps in more than 18 months to correct them.
The warning letter does not force Hospira to stop manufacturing or halt any operations. The company must submit a proper plan for addressing the conditions at the facility that led to the recall last year.