FDA Exerts FSMA Authority - Food Safety

Updated June 24, 2024

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New Era of Smarter Food Safety - FDA.gov

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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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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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Related articles

• FDA Increases Winery Inspections (drughealth.blogspot.com)

FDA Public Hearing on Antiseptic Patient Preoperative Skin Preparation Products

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Updated October 12, 2022

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Safety and Effectiveness for Health Care Antiseptics; TopicalAntimicrobial Drug Products for Over-the-Counter HumanUse; Proposed Amendment of the Tentative Final Monograph;Reopening of Administrative Record - FDA.gov (PDF)  

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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 upcoming Flu Season - from the CDC

Updated May 7, 2019

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Influenza (Flu) - CDC:  Learn about the current flu season & treatments, and more!


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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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