Problems at Hospira Infusion Pump Plant Result in FDA Warning

Hospira has received an FDA warning letter over conditions at an infusion pump factory in Costa Rica, which the agency has deemed to be unacceptable. 

Following an FDA inspection at a Hospira plant in La Aurora de Heredia, Costa Rica, where the company manufactures their Symbiq, Plum, Gemstar and Lifecare PCA infusion pump brands, the agency sent a letter last week, indicating that the plant had failed to correct and properly monitor qualify control problems.

According to the warning, FDA officials indicate that the plant failed to prevent recurring problems with nonconforming products, such as a failure of audible alarms on Plum infusion pumps that led to a February 2011 recall.

The alarm on Hospira Plum pumps was redesigned by the supplier, but in March 2012 the company again began receiving complaints of the same problem.

The plant also had issues implementing and recording changes that were needed to correct quality control problems. The inspectors again brought up problems with the Plum infusion pump as an example, and found that plant workers were given outdated instructions on the assembly of some parts and failures to conduct the proper visual inspections.

Other problems included failures to evaluate suppliers’ abilities to actually meet the needs of the plant and of failure to establish adequate procedures to accept products coming into the plant. The plant’s record-keeping practices were also lacking, investigators found.

The company has 15 days to respond to the letter, which was dated August 22, or else face possible fines and seizure of products. The FDA noted that follow-up inspections would be needed to ensure whatever plan is implemented is done so correctly.

The warning letter comes just days after Hospira announced a hydromorphone recall due to overfilled syringe cartridges. It is the third drug recall this year, all of them were opioids which could cause lethal overdoses.