Hospira Medical Device Manufacturing Problems Get FDA Warning

Federal regulators have warned Hospira Inc. over the quality of its medical devices, following an inspection of its Lake Forest, Illinois production facility. 

The company alerted investors on Wednesday during conference call that it has received a warning letter from the FDA that includes a list of problems inspectors discovered at the production plant. The letter admonished the company over how it handles complaints, medical device reporting and supplier quality problems.

The letter comes on the heels of at least 11 recalls and device corrections issued by Hospira in just 2013 alone.

In late January, Hospira issued a Lactated Ringers and 5% Dextrose recall after a customer found spore-like material in the caloric fluids that looked like mold. The company also issued a device correction about some drug infusion pumps that need to be either repaired or recalled, the company told investors. They also warned that more device notifications were going out soon, but promised that they would be less frequent.

The Lake Forest facility is not the only one facing problems. The FDA is currently investigating the company’s Rocky Mount, North Carolina, factory after repeated problems, and its Clayton, North Carolina plant has just begun manufacturing propofol again after it was temporarily shut down.

Last summer, the company received another FDA warning over its plant in La Aurora de Heredia, Costa Rica, where it manufactures its Symbiq, Plum, Gemstar and Lifecare PCA infusion pumps due to recurring problems.

Last year also saw Hospira recall a number of drugs, including a hydromorphone recall over possible overdose risks, a morphine recall due to similar problems, a Symbiq infusion pump recall over a defective touchscreen and a carboplatin injection recall issued over particulate matter contamination.