FDA Compliance

@registrarcorp

Enjoying a positive reputation worldwide, Registrar Corp helps companies to navigate compliance standards set forth by the United States Food and Drug Administration (FDA). Registrar Corp provides services to companies in industries related to the manufacture, distribution, and sales of food and beverages, medical devices, drugs, and cosmetics. While not affiliated with the FDA, Registrar Corp carefully reviews and stays up to date on all registration, US agent, and compliance regulations. The company has more than 10 years of experience with compliance issues and employs a team of regulatory specialists. The team includes former FDA officials and scientists, who can offer clients real-world expertise.

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FDA Import Refusals due to Labeling Violations

Because every country has its own labeling requirements, it is common for exports to be refused entry to the U.S. because of labeling violations. The U.S. Food and Drug Administration (FDA) has strict labeling requirements for all food and beverages distributed in the United States. Registrar Corp is bringing you the top five labeling mistakes that lead to import refusals.

Label has insufficient nutritional information

All ingredients are not listed on the label

Label is not completely in English

Label does not state the quantity of the contents

Label does not state the name and place of business of the manufacturer, packer, or distributor

If you need help bringing your product labels into compliance with FDA requirements, Registrar Corp can help. We offer a label review and modification service through which our Regulatory Specialists will evaluate your label and return to you a print-ready graphic file that includes suggested edits.

Food Facilities Registered with FDA Reduced by Half

The Food Safety Modernization Act (FSMA) requires that food facilities renew their registrations between October 1 and December 31 of each even-numbered year. From 2012 to 2014, the number of food facilities registered with the U.S. Food and Drug Administration (FDA) was reduced by half. 2012 was the first time that food facilities were required to renew their FDA registrations under FSMA. …

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FDA Dashboard Reveals Inspection Statistics

The U.S. FDA has created a new data dashboard that contains graphical data about FDA inspections and enforcement. Users can see the final actions of FDA inspections organized by country and/or FDA center (CFSAN, CDER, etc.), and see trends in FDA inspectionsover the last 5 years. As of now, the dashboard contains inspection data from FY 2009 to FY 2013. FDA will update the information in the…

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FDA Reportable Food Registry

Food facilities registered with the U.S. FDA are required to report all food that has a reasonable probability of causing harm or death to humans or animals upon exposure or consumption. Facilities have 24 hours after realizing the potential danger to submit the food to the Reportable Food Registry (RFR). The facility must investigate the cause of the adulteration and include its findings in its RFR submission. FDA released the RFR in 2009 so that it could track patterns of adulteration in food and target inspections more easily.

One example of a food that would need to be reported to the RFR is a cookie with a label that does not specify that it contains peanuts. If a consumer with a nut allergy bought the cookie and ate it, they could be harmed. Another example would be a food item that a facility learns may contain salmonella.

The RFR is only available in English. If you need help translating the RFR into a different language, or if you need help determining whether or not to report a food to the RFR, Registrar Corp can help.

The registration renewal requirement was established by the Food Safety Modernization Act (FSMA) in 2011 and requires that food facilities renew their FDA registrations between October 1 and December 31 of every even-numbered year.

Learn more at www.registrarcorp.com

#fda registration renewal #fda registration #food facility

The U.S. Food and Drug Administration (FDA) Medical Device Registration and Listing Module (DRLM) will be unavailable from 6PM EDT on Friday, September 26, 2014

This FDA news is brought to you by Registrar Corp.

#FDA #medical devices #medical device registration and listing module #DRLM

U.S. Court Declares that FDA has Violated FSMA and the APA by Failing to Promulgate the FSMA Regulations by the Statutory Deadlines

Learn about the impact of this decision here.

This FDA news update is brought to you by Registrar Corp.

#FDA #us court ruling #FSMA

Registrar Corp just wrapped up presentation of an FDA regulatory seminar about new FSMA regulations at Vietrade 2014! David Lennarz, VP of Registrar Corp, helped local Vietnamese businesses understand how to successively navigate and comply with the new FSMA rules to optimize their export efforts.

The Vietnamese food and beverage industry is seeing bright prospects for exports to the U.S. (read article published in The Voice of Vietnam magazine online here).

#FDA #FSMA #FDA regulations #seminar #vietnamexports #vietnam

"NASDA expressed concern that, because FDA had little experience dealing with agricultural policy, FDA’s proposed regulations could result in damage to domestic production of fruit and vegetables."

sponsored by: http://www.registrarcorp.com

#fda #food #food safety #agriculture

Rumors of Roquefort Cheese's Demise Greatly Exaggerated

If one is to believe the headlines, the FDA has banned the moon. And the moon is made of Roquefort cheese.

The actual story is that FDA had set a certain food safety threshold for a “non-toxigenic” E.coli bacteria back in 2010. When a number of specialty cheeses tested above that threshold, FDA issued warning letters. FDA responded to the artisan cheese industry’s protests by reviewing the…

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Visit http://www.registrarcorp.com for assistance with food facility registration renewals, which are due Oct. 1 - Dec. 31 2014. We can help!

#cheese #FDA #food #Food and Drug Administration #food safety #warning letter

Registrar Corp is heading to Baltimore, Maryland this week for Natural Products Expo East, the leading trade show on the East Coast for the natural, organic, and healthy products industry.

#fda #natural #organic #food regulations #facility registration

Many companies don’t consider their online presence when working to comply with FDA regulations. What many don’t know is that FDA considers websites and social media to be an extension of product labeling...

#fda labeling regulations

What You Need To Know About FDA Registration Renewal 2014

FDA Registration Renewal 2014 infographic via http://fda-news.registrarcorp.com

With FDA registration renewal deadlines for food facilities looming, there are some important changes which the U.S. Food and Drug Administration has been mandated by legislation called “FSMA” to implement.

According to FDA’s website guidance documents these changes in regulatory oversight of the United States food…

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Visit our website to learn more about FDA detentions and import alerts.

#fda #customs broker #Registrar Corp #fda consultants #fda detentions #fda import alerts #shipments detained by fda

Registrar Corp supplies the Horticulture International Department of Horticultural Science at NCSU with FDA registration assistance resources.

To learn more about our services, visit us at www.registrarcorp.com

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With less than a month to go, food facilities are proactively getting prepared for FDA registration renewals!

#fda registration #food facility #registration renewal #Registrar Corp

FDA renewal period for food facilities is less than one month away! Learn more here.

#fda #food facility #registration renewal

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