FDA Investigated NECC For Sterility Issues A Decade Ago
The most recent shutdown of the New England Compounding Center is apparently not the first time that the facility has been the target of regulators. A House panel convened in order to look into a recent meningitis outbreak stemming from the NECC’s distribution of contaminated steroid inspections has summarized how the Food and Drug Administration… read more
Meningitis Outbreak Leads to FDA Inspection and Calls for Oversight
Following a widespread meningitis outbreak that has affected hundreds of lives and killed dozens, members of the government are calling for new oversights that could help prevent such an incident in the future. The New England Compounding Center was responsible for distributing the contaminated steroids thought to be responsible for the outbreak, and the Food… read more
Potential Regulatory Violations Uncovered at NECC Facility
Following weeks of reports about a meningitis outbreak affecting states across the entire country, the Food and Drug Administration is now reporting that the facility responsible may indeed have suffered from conditions that might constitute a potential regulatory violation. This information was confirmed by way of a 483 form, which is filed by FDA investigators… read more
Authorities Look Into Widely Advertised 1-800-GET-THIN Clinics
If you live in Southern California, you’ve no doubt seen the signs. There was a time when they were inescapable. 1-800-GET-THIN promotions dominated the landscape, advertising the Lap-Band weight loss procedure to the denizens of California. But the company behind those signs is now being investigated for possible breaches of the law. The 1-800-GET-THIN clinics… read more
FDA Examines Kefauver-Harris Amendments’ Impact on Drug Safety
In honor of the 50th anniversary of what’s known as the Kefauver-Harris Amendments, the passage of which became a landmark in drug safety, the Food and Drug Administration is looking into the history of this moment and its impact on the country. In the late 1950s, Senator Estes Kefauver led a Subcommittee that sought to… read more
NECC Raided by FDA On Heels of Meningitis Outbreak Investigation
The investigation continues into what exactly led to 14,000 people potentially being placed at risk of suffering a meningitis infection stemming from a contaminated steroid injection. Now comes word that not only could the investigation into the New England Compounding Center be expanded, but that agents with the Food and Drug Administration have raided that… read more
Consumers Warned of Tattoo Ink Danger In Wake of Infections and Recall
The Food and Drug Administration wants consumers to know the danger that exists with contaminated tattoo inks. Some recalled tattoo inks have been linked to an outbreak of nontuberculous Mycobacteria that has led to reports of serious infections in four separate states. Once the organization was alerted to potential infection stemming from a New York… read more
FDA Warns Forest Labs to Correct Alleged Product Promotion Violations
Forest Labs was recently the recipient of a warning letter from the Food and Drug Administration alleging that the company’s sales reps had violated laws regarding promotional practices. This and another letter issued in April of last year came on the heels of a September 2010 settlement with the Department of Justice over similar allegations. … read more
FDA Alerted to Potential Ice Cream Safety Issues at Penn State
The Food and Drug Administration has been alerted to a potential safety issue at Penn State in University Park, Pennsylvania. Concerns arose when a customer at the campus’s Berkey Creamery reported finding a penny in their ice cream. Since then, three additional reports of plastic turning up in ice cream at the site have become… read more
Report Shows Kids’ ADHD Meds On The Rise While Antibiotics Fall
A new report from the Food and Drug Administration is causing some to rethink the way that certain medications are given to children. The report, which was published in a journal known as Pediatrics, looked at the number of prescriptions that were issued to children since 2002, a ten year timespan. What the FDA found… read more
FDA Gives Implanted Blood Access Devices Less Stringent Regulation
The Food and Drug Administration has deemed certain medical devices as being safer than they previously were. The agency has just released draft guidance which concerns a type of medical product known as an implanted blood access device. Such technology usually takes the form of cannulae, catheters, and hollow needles that work by placing a… read more
Judge Tells FDA to Reconsider Livestock Antibiotic Petition
A judge is telling the Food and Drug Administration to reconsider their position on a petition filed in order to get the organization to look into the safety of animal feed antibiotics. In both 1999 and 2005, concerned citizens requested that the FDA withdraw medically important antibiotics from animals that would be used as livestock. … read more
