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The U.S. Food and Drug Administration (FDA) recently suspended the food facility registration of SM Fish Corp, located in Far Rockaway, NY, following a failed re-inspection and re-sampling of their ready–to-eat (RTE) seafood products. June 14, 2016 to July 6, 2016 revealed that several environmental samples tested positive for Listeria. FDA requested that SM Fish Corp. recall some of it RTE products and shut down briefly to revise its cleaning and sanitation procedures, to which the facility agreed.

Following the initial inspection SCORE, a decision making body of individuals intended to ”ensure the agency engages in an integrated approach to identifying timely and efficient measures in order to help mitigate public health risks,” requested a re-inspection of SM Fish Corp. in order to ensure the problems found at the facility were resolved.

The decision to suspend the facility’s registration was made under the authority of the 2011 Food Safety Modernization Act (FMSA) after FDA’s re-inspection in August 2016 revealed a continued widespread Listeria contamination within the facility. As a result of this suspension, SM Fish Corp. is banned from marketing food in the United States. FDA may lift the suspension only when the agency determines the facility’s food no longer has reasonable probability of posing serious health issues or death to human consumers.

Facilities are often unaware of the cost and time associated with FDA re-inspections. When FDA initially inspects a food facility, it is financed by the agency, but if FDA finds reason to re-inspect, the agency may charge re-inspections fees. For facility re-inspection fees, FDA will invoice the responsible party for the direct hours; including time spent preparing and traveling, at the appropriate hourly rate. The FY 2017 hourly rates for FDA re-inspections are as follows:

  • $221 per hour for domestic facilities
  • $285 per hour when foreign travel is required

It is crucial to prepare for possible FDA inspections in order to prevent costly
re-inspections that may lead to the suspension of your food facility registration. Registrar Corp can assist facilities preparing for FDA inspections. A Food Safety Specialist can perform mock FDA inspections  at the request of both foreign and domestic facilities to help identify any potential problems and help facilities to better understand FDA’s expectations. Additionally, if your foreign food facility utilizes Registrar Corp as its U.S. Agent, Registrar Corp will perform a mock inspection free of charge (other than travel and lodging expenses) when FDA issues a Notice of Inspection for that facility.

For more information or assistance regarding FDA inspections, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor
24-hours a day at www.registrarcorp.com/livehelp.

 

         

Registrar Corp writes to remind the food industry of an important upcoming regulatory deadline.  Under the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), food facilities that manufacture, process, pack, or store food for distribution in the United States are required to renew their FDA registrations between October 1 and December 31, 2016.

Food facilities have been required to register with FDA since 2003. FSMA updated this requirement in 2011 to include biennial renewals in order to keep FDA’s registration database up-to-date.  Food facilities are now required to renew every even numbered year between October 1 and December 31.

FDA’s Registration Renewal requirement applies to both domestic and foreign food facilities registered with FDA.  Foreign facilities must also designate a U.S Agent for FDA Communications in Section 7 of their renewal.  It’s important to designate a professional knowledgeable on FDA regulations , as this U.S. Agent will have access to information submitted in the facility’s registration and may speak on behalf of the facility to FDA regarding inspections, shipments, and other regulatory matters.

Facilities must renew their FDA registration no matter when they submitted their initial registration.  A facility could have registered with FDA one month or even one day before October 1, and the facility would still need to renew.  If a facility does not renew its registration by December 31, FDA will consider the registration to be expired.  Distributing food in the United States with an expired registration is a prohibited act and may lead to detention of products or other regulatory action by FDA.

There was a 14% decrease in the number of food facilities registered with FDA from January 2014 to January 2015.  Registrar Corp believes the drop was due to facilities failing to renew their registration during the 2014 renewal period.

Registration renewals may be completed directly with FDA by mail, fax, or online, or facilities may authorize a third party individual to complete their renewal.

Registrar Corp is a U.S. FDA consulting firm that helps food facilities comply with FDA regulations, including registration, U.S. Agent requirements, food labeling, and new requirements under the Food Safety Modernization Act.  Registrar Corp’s Regulatory Specialists register and renew thousands of food facilities each year and act as the U.S. Agent for over 13,000 facilities around the world.  Contact Registrar Corp for assistance.

This article was originally published as a press release.

         

On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule on the effectiveness and safety of over-the-counter (OTC) antibacterial soaps. This final rule affects consumer antiseptic wash products for both hands and body which contain the frequently used ingredients triclosan and triclocarban as well as 17 other active ingredients (See 81 FR 61110 for a full list of eligible ingredients).  Beginning September 6, 2017, companies that manufacture and market affected antibacterial soaps may not legally introduce or deliver for introduction their products into interstate commerce unless approved under a new drug application.

FDA first proposed this rule in 2013 after research suggested that long-term use and exposure to specific active ingredients used in antibacterial soaps may cause a health risk to consumers. Examples of these health risks include hormonal effects and bacterial resistance.   According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER), “Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water.”

FDA has postponed a rule making decision for consumer antiseptic soaps and washes that contain the ingredients- benzalkonium chloride, benzethonium chloride, and cloroxylenol (PCMX) for one year to allow industry to provide additional safety information. FDA will take regulatory action at that time, dependent upon whether the data provided by industry supports the conclusion that those active ingredients are generally recognized as safe and effective for this intended use.

FDA’s final rule only applies to consumer rinse-off antibacterial soaps.  This final rule does not affect consumer no-rinse handnitizers or antibacterial products used in hospital or health care settings.

Registrar Corp can help manufacturers determine whether their product is affected by FDA’s final rule.  For questions or assistance with the compliance of the final rule on antibacterial soaps, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.come/livehelp.

 

         

On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued an extension to the Unique Device Identification (UDI) compliance deadline for certain class II devices. The original compliance date of September 26, 2016 for the UDI label and submission of data to the Global Unique Identification Database (GUDID) has been extended to September 24, 2018.

The extension to the UDI rule applies to the following class II devices and constituents of certain combination products:

  1. Collections of two or more different devices packaged together in which the devices in the package are not individually labeled
  2. Repackaged single use devices (This extension does not apply to implantable, life-supporting or life sustaining devices.)
  3. Combination products assigned to FDA’s Center for Drug Evaluation and Research (CDER) or FDA’s Center for Biologics Evaluation and Research (CBER) for premarket review

FDA extended the compliance deadline for collections of two or more different devices packaged together to allow the agency time to finalize their draft guidance document titled “Unique Device Identification: Convenience Kits: Draft Guidance for Industry and Food and Drug Administration Staff.”  The deadline for repackaged single use devices is extended only to single use devices that are not individually labeled with an UDI.

Other class II devices are still required to comply with FDA’s UDI rule by September 24, 2016.  Click here for tips for meeting this month’s deadline.

The UDI rule created a system that aims to identify medical devices from their distribution to the supply chain point of use with patients.  Registrar Corp put together a short video on FDA’s UDI requirements.

For assistance with FDA’s UDI requirements or determining your compliance date, contact Registrar Corp at +1-757-224-0177 or talk to a Regulatory Advisor at www.registrarcorp.com/livehelp 24 hours a day.

 

         

The compliance date for device labelers to place Unique Device Identifiers (UDIs) on their Class II devices is approaching quickly.  Under the U.S. Food and Drug Administration (FDA) final rule, Class II devices must be labeled with UDIs starting September 24, 2016.  FDA consulting firm Registrar Corp is providing tips to help labelers of Class II devices meet the impending deadline.

Tip 1: Determine the Labeler

FDA puts responsibility for UDI compliance on the “labeler” of a medical device.  FDA’s definition of a labeler can confuse companies trying to comply.  Typically, the labeler is the owner of the brand.  When the manufacturer does not own the brand, the manufacturer is likely not the labeler.  For example, if RegMed buys catheters from CBI Medical Products and markets the devices under RegMed’s brand, RegMed would likely be considered the labeler of the catheters. Click here for more information on identifying the labeler of a device.

Tip 2: Start Immediately

If you determine you are responsible for complying with FDA’s UDI requirements, it’s prudent to start as soon as possible.   Many aspects of UDI compliance can take substantial time to accomplish.  For example, FDA requires that device facilities obtain a DUNS number for UDI purposes.  DUNS numbers are free to obtain, but it can take Dun and Bradstreet weeks to issue a new number.  Registrar Corp can help facilities obtain a DUNS number free of charge.  Device labelers also are required to identify a Global Medical Device Nomenclature (GMDN) for each device they submit to FDA’s Global Unique Device Identification Database (GUDID).

Tip 3: Practice Makes Perfect

Submitting data into FDA’s GUDID can be time consuming and complicated.  FDA recommends that labelers using the agency’s web interface or the HL7 SPL method familiarize themselves with the system before submitting.  Web interface users may create draft submissions which are not visible to FDA.  Alternatively, Registrar Corp can submit device data to FDA’s GUDID on behalf of a labeler.

Tip 4: Appoint a Knowledgeable Regulatory Contact

FDA requires device labelers to designate a Regulatory Contact when creating a GUDID account.  FDA will contact this individual with questions regarding GUDID submissions as well as compliance and regulatory issues.  The Regulatory Contact speaks on behalf of the company, so it’s important to designate a professional familiar with FDA’s UDI rule.  Registrar Corp employs several UDI specialists and can act as a company’s Regulatory Contact.  As a company’s Regulatory Contact, Registrar Corp will setup the company’s GUDID account, help determine the UDI requirements applicable to the company’s specific devices, and facilitate communication between FDA and the company.

For additional guidance, see Ten Steps to Comply with FDA UDI Regulations.

This blog was originally published as a press release.

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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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