Time after time in the past two years, a Norcross mammography clinic has failed FDA inspections, and now the federal agency is warning MRI Imaging Specialist that it could face fines of up to $11,000 a day if it doesn't address the violations.
Most serious, the Food and Drug Administration alleges: the company has no system to ensure that patients promptly get their exam results. The FDA says that violation represents a serious risk to patients. Among other violations alleged: a faulty tracking system for positive mammograms.
Inspections in 2014 and 2015 uncovered problems that a follow-up inspection early this year found still hadn't been addressed, the FDA says.
Credit: Lois Norder
Credit: Lois Norder
"Because the continued failure to resolve these violations may be indicative of serious underlying problems that could compromise the quality of mammography at your facility, FDA may take additional actions," the letter says.
That could include suspending or revoking the company's FDA certificate, civil penalties of up to $11,000 a day or increased FDA oversight.
The Jimmy Carter Boulevard clinic, listed as being owned by Miguel Leon, was given 15 days to respond.
More FDA news:
Little shop of medical horrors
Exploding portable emergency oxygen systems; cancer-causing ingredients in a weight loss product; bacteria-tainted IV fluid replacement; unreliable Reliable Drug compounded medications.
That's one week's roundup of recalls announced by the Food and Drug Administration. Scary as they seem, the recalls were a long time coming.
First reports of exploding oxygen canisters came in 2013. But it wasn't until late March that the FDA recommended that sch0ols, businesses and health care providers stop using the OxySure Portable Emergency Oxygen System, Model 615. FDA notes in the recall announcement that it had warned the company of safety issues during inspections, but the company had failed to address them, leaving people at risk of burns and death.
Thousands of people may already have taken the weight loss product Propell Platinum, before the FDA warned that it contains sibutramine. But back in 2010, the U.S. and other countries removed that substance from the market because of the risk of heart attack and stroke. Another hidden ingredient in Propell Platinum also is associated with a cancer risk, FDA says. But the U.S. doesn't require that dietary supplements like Propell Platinum be analyzed before they're marketed.
And so on. Full list of FDA recalls and safety alerts is here.
