Hospira, a medical device manufacturer based in Lake Forest, Illinois, received a Form 483 letter from the United States Food and Drug Administration due to concerns over manufacturing practices at the company. The company is currently under close scrutiny due to issues with some of its infusion pumps.
According to information from the FDA, a Form 483 letter is not a formal warning and does not place any restrictions on Hospira’s practices. However, the letter does include 10 different “objectionable conditions” that could preclude a formal warning.
Hospira shared news of the Form 483 letter in a conference call on Wednesday. Michael Ball is the CEO of Hospira. During the conference call, he said, “The observations re-enforced our own assessment that there is still a lot of work to be done within our device operations.”
In August of 2012, Hospira received a formal warning letter from the FDA due to quality control issues at its manufacturing plant in Costa Rica. In November of last year, the FDA banned the import of Hospira’s Symbiq infusion pumps that were manufactured at the plant.
Last year, St. Jude Medical received a similar Form 483 letter from the FDA. Less than 90 days after receipt of the letter, St. Jude was slapped with a formal warning from the FDA. For Hospira, a formal warning (or worse) could be on the horizon.