UPDATED: Hospira back in FDA's sights over device manufacturing

Hospira CEO F. Michael Ball

Hospira ($HSP) disclosed that it received a Form 483 from the FDA over how it manufactures medical devices at its Illinois headquarters, another blow as the company struggles to stay out of the agency's doghouse with its infusion pumps.

Form 483 is not a warning letter and doesn't come with the attendant restrictions, but the FDA's list of 10 objectionable conditions could be a precursor to formal action. Hospira revealed the agency's action on an investor call Wednesday, Reuters reports, and CEO F. Michael Ball said regulators acknowledged that the company is working to correct its device manufacturing.

But the road to redemption got a little rockier Thursday. In November, the FDA outright banned Hospira from importing the Symbiq infusion pumps made at its Costa Rica plant, and now the agency has extended its ruling to cover the Plum, GemStar and LifeCare PCA models, Hospira revealed in a regulatory filing.

If the ban stays in effect through the year, it could end up slashing between $50 million and $100 million from annual sales, the company said, and Hospira has now withdrawn its full-year forecast, issued just one day earlier.

And that's likely not the last Hospira will hear from the agency, as the latest Form 483 could put the company in further peril--St. Jude Medical ($STJ) received the same slip last year and wound up with a full warning letter about three months later.

Hospira's shares have dropped about 7.3% since the announcement, its biggest one-day decline in more than a year.

- check out Hospira's filing
- read the Reuters story

Editor's note: This story was updated to reflect Hospira's Thursday SEC filing.

Suggested Articles

Coronavirus may not require a front-line battle yet in certain places, but it’s still taxing public health officials preparing for a potential crisis.

Cybernet Manufacturing, maker of medical-grade computer monitors, has unveiled a new, large touchscreen designed to protect against infections.

A startup has raised $12 million to fund its real-time system for monitoring patients undergoing dialysis at home and calling in complications.