Sunday, December 23, 2012

FDA Exerts FSMA Authority - Food Safety

FDA Writing New Chapters in Food Safety History | FDA Voice:

"With the suspension of Sunland’s food facility registration, for the first time FDA was, in effect, able to independently prevent a company from distributing food that could have caused harm to consumers. This was our first use of this new authority granted by the FDA Food Safety Modernization Act (FSMA), and it will be an important tool for FDA to use in the future to ensure the accountability of companies for the safety of the food they produce.

Under the decree, Sunland must hire an independent sanitation expert to develop a program to ensure products are produced in a sanitary way and according to good manufacturing practices. The company must also conduct environmental testing to ensure that disease-causing bacteria aren’t present in its facility or in its final food products. FDA will evaluate the programs Sunland sets up, and will not allow the company to operate its peanut butter plant until we determine that its products can be safely produced. "

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Tuesday, December 18, 2012

GMP Master Training Plans - Free Tips (Video)

Watch this video for free tips on GXP, QSR, and GMP Master Training Plans.

 

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Food Safety Regulations Backlog Affects FDA and USDA

Backlog for Food Safety Regulations Includes Both FDA and USDA | Food Safety News:

"Everyone knows about the food safety rules held up by “oh-eye-rah,” or as it is formally known at the White House, the Office of Information and Regulatory Affairs (OIRA). But it’s not just the U.S. Food and Drug Administration (FDA) that is waiting; the U.S. Department of Agriculture (USDA) also has food safety rules on hold too.

OIRA – the executive branch’s regulatory referee – has recently turned into a  bottleneck for the rules FDA needs to implement the new Food Safety Modernization Act.  The Act has been the subject of a lot of attention and, in recent months, even a lawsuit. A USDA rule requiring meat businesses to improve grinding logs and inventories, however, has gone relatively unnoticed, but this law is also held up by the powerful little White House office."

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Wednesday, December 5, 2012

FDA Public Hearing on Antiseptic Patient Preoperative Skin Preparation Products

News & Events > Antiseptic Patient Preoperative Skin Preparation Products:

"The Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on how to address microbial contamination of patient preoperative skin preparation drug products. Currently, patient preoperative skin preparations are not required to be sterile, and bacteria can contaminate these products at the time of manufacture or during product use. Contaminated patient preoperative skin preparations have been associated with clinical infections and adverse outcomes. At this public hearing, FDA is interested in obtaining public comment about certain scientific and product use issues related to patient preoperative skin preparations"

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Meeting Details:

Date(s):      December 12 - 13, 2012
Time:           9:00 a.m. to 4:00 p.m.
Location:     DoubleTree by Hilton Hotel Washington DC/Silver Spring
                      The Ballrooms
                      8727 Colesville Road
                      Silver Spring, MD 20910

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What You Should Know for the 2012-2013 Flu Season - from the CDC

Follow the link below to checkout the CDC's very comprehensive Q & A webpage. Lots of answers to just about every question you might ask.

CDC - Seasonal Influenza (Flu) - What You Should Know for the 2012-2013 Influenza Season:
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Tuesday, December 4, 2012

FDA Increases Winery Inspections

FDA Takes a Growing Interest in Winery Safety | News | News & Features | Wine Spectator:

"While winery inspections are not new, they’re being ramped up under the 2011 Food Safety Modernization Act, according to FDA spokeswoman Patricia El-Hinnawy.

The federal law mandates that the FDA inspect all food processing establishments. The frequency of inspections is based on safety risk and compliance history. While wineries are considered low risk because the fermentation process kills pathogens, all food facilities must be inspected within seven years and at least once every five years after that. “The FDA may be conducting more inspections [at wineries] than it has done in the recent past, in order to meet the [law’s] requirements,” El-Hinnawy said."

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Saturday, December 1, 2012

FDA on the Ranbaxy Atorvastatin Recall

The FDA is providing additional related information. Just follow the link below.

Drug Safety and Availability > FDA Statement on the Ranbaxy Atorvastatin Recall:

"FDA Statement on the Ranbaxy Atorvastatin Recall

Update: 11/30/2012
FDA is notifying the public that after reviewing additional information related to the Ranbaxy atorvastatin recall, FDA has determined that the possibility of adverse health problems related to the recalled atorvastatin is extremely low.

What patients should know . . . "

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World AIDS Day - FDA Voice

Fda
World AIDS Day | FDA Voice:

"The Food and Drug Administration supports the fight against HIV/AIDS by promoting medical innovation, protecting the blood supply, and reviewing and regulating new and existing medical products, including devices used in prevention, such as condoms and medical gloves. Doctors, nurses, pharmacists, scientists and many others at FDA have worked hard in 2012 to make sure that there are safe and effective medical products and devices available to fight HIV/AIDS."

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