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FDA Raises Food Facility Re-Inspection Fees for 2021

The U.S. Food and Drug Administration announced that it will raise re-inspection fees for domestic and foreign food facilities during the Fiscal Year (FY) of 2021. The fee for re-inspection of a foreign facility in FY 2021 will be $310/hr, an increase from $301/hr in FY 2020. The fee for re-inspection of a domestic facility in FY 2021 will be $263/hr, an increase from $258/hr in FY 2020. The new fees will be effective October 1, 2020 through September 30, 2021.

FDA does not impose fees for routine inspections, however if an inspection reveals significant violations to food safety, FDA may conduct a re-inspection, in which case the fees may be assessed. The Food Safety Modernization Act (FSMA) authorizes FDA to assess and collect hourly fees for re-inspections of non-compliant facilities to cover the cost of salary, travel, and anything else related to conducting the re-inspection. These fees are assessed for any time spent on “whatever components of such an inspection are deemed necessary” and the final cost can escalate to thousands of dollars.

Common Food Safety Violations

To help avoid a costly re-inspection, it is prudent to be aware of common food safety violations.

Some of the most common food safety violations that may prompt re-inspection are not properly dealing with pests, not maintaining sanitation protocol, not correctly implementing a HACCP plan, and personnel issues. FDA also commonly cites facilities for issues with their Food Safety Plans.

With the increase in re-inspection fees, it is critical to be compliant with FDA food safety requirements and be prepared for an inspection when the time comes. In addition to the risk of re-inspection, FDA may also issue warning letters or suspend a facility’s registration for infractions found during an inspection, causing further delays and costs.

Registrar Corp is a private company that assists businesses in complying with FDA regulations. We can help your facility prepare for an FDA inspection with our Mock Inspection service as well as assist your facility in developing a HARPC food safety plan or a HACCP food safety plan to avoid citations. For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livechat.

FSPCA Approves Registrar Corp as the First 100% Online and Self-Paced “FSPCA Preventive Controls for Human Food” Course Provider

Leading FDA advisory and training firm Registrar Corp announced today the release of the first ever fully online and self-paced “FSPCA Preventive Controls for Human Food” course approved by the Food Safety Preventive Controls Alliance (FSPCA) and which includes the FSPCA certificate.

This course uses the standardized curriculum recognized by the U.S. Food and Drug Administration (FDA). Successfully completing this course meets the requirements for becoming a Preventive Controls Qualified Individual (PCQI). Food industry professionals can now become PCQIs at their own pace and from the comfort of their home or office.

“Given the challenges of travel and in-person training during COVID, we’re excited that the FSPCA has recognized the demand for this type of fully online PCQI training,” said David Lennarz, President of Registrar Corp.

FDA defines a PCQI as someone who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to this standardized curriculum or is otherwise qualified through job experience to develop and apply a food safety system.  Participants who complete Registrar Corp’s online course will receive a certificate from the FSPCA Institute for Food Safety and Health (IFSH), the Association of Food and Drug Officials (AFDO), and the International Food Protection Training Institute (IFPTI). This certificate demonstrates that the participant has completed training that qualifies them to be a PCQI and is only given to individuals who complete the FSPCA-recognized course.

The standardized course curriculum was developed by the FSPCA, a public-private partnership created by FDA to develop training that promotes safe food production and compliance with FDA’s Preventive Controls rules.  The Preventive Controls Rule requires most facilities that manufacture, process, pack, or store food to designate a PCQI who will oversee and implement the facilities’ Food Safety Plans.

Click here to learn more about Registrar Corp’s online PCQI course.

The PCQI online training course is just one of many online courses that Registrar Corp offers for food safety professionals.  In July 2020, the FSSC 22000 food safety certification program approved two of Registrar Corp’s FSSC 22000 courses, which prepare facilities to implement a GFSI-recognized food safety scheme.  Registrar Corp also offers courses on SQF and ISO Implementation, Internal Auditing, HACCP, allergen management, and much more.  Click here to explore all of Registrar Corp’s online training offerings.

If you have questions about PCQI requirements or Registrar Corp’s online courses, contact Registrar Corp’s training department at [email protected] or by calling +1-757-224-0177 (option 5).

About Registrar Corp

Registrar Corp is the leading provider of U.S. Food and Drug Administration (FDA) compliance services. Since opening its Hampton, Virginia headquarters in 2003, Registrar Corp has expanded to 20 worldwide offices and has aided more than 50,000 companies across 160 countries. In March 2020, Registrar Corp acquired Vinca, LLC (dba ‘www.22000-Tools.com’) and added Vinca’s array of online food safety courses to their comprehensive suite of FDA compliance services.

Food Facilities Need Unique Facility Identifiers (UFIs) Beginning October 1, 2020

MARCH 2021 UPDATE: FDA extended the deadline to obtain a Unique Facility Identifier to December 31, 2022.  Learn more here.

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The U.S. Food and Drug Administration (FDA) has indicated that food facilities will be required to provide a Unique Facility Identifier (UFI) when registering with FDA or renewing an FDA registration beginning October 1, 2020 (21 CFR 1.232 (a)(2)).

All FDA-registered food facilities are required to renew their FDA registrations between October 1 and December 31, 2020.  Failure to renew will result in a cancelled FDA registration, and it may not be possible for a facility to complete this required renewal without a UFI.  Thus, it is prudent for facilities to obtain UFIs as soon as possible.  As the 2020 renewal period approaches, more facilities will be applying for a UFI in order to meet this new requirement.  A backlog of UFI requests may cause industry to experience delays in receiving their UFI.

How do I obtain a UFI?

As of July 13, 2020, section F2.3 in this FDA guidance stated that Data Universal Numbering System (DUNS) numbers are currently the only UFI recognized by FDA.

Get Your UFI – Start the Process Today

Registrar Corp can help food facilities obtain a DUNS number as part of our Registration and U.S. Agent services.  In addition to DUNS assistance, our Regulatory Specialists will assure your registration is properly renewed during the 2020 renewal period as part of this service.

Get Started

Contact Registrar Corp today to learn more about FDA’s new UFI requirement and to get help to obtain a DUNS number for your facility.  You can reach us by email at [email protected] or by phone at +1-757-224-0177.  You can also chat online with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livechat

FDA Introduces Annual Fee for OTC Monograph Drug Facilities

Update: FDA published the FY 2021 OMUFA Facility Fees on December 29, 2020.

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In March 2020, the US President signed a COVID-19 relief legislation titled the CARES Act. This legislation included an initiative that “reforms and modernizes the way certain nonprescription, over-the-counter (or OTC) drugs are regulated in the United States.”

One of the key components of this OTC reform is the Over-the-Counter Monograph User Fee Act, or “OMUFA”, which introduces annual facility fees for OTC monograph drug facilities, including contract manufacturing facilities. The new facility fees are intended to provide FDA with additional resources to conduct OTC monograph activities, such as reviewing submissions, in a timely manner.

What is an OTC Monograph Drug Facility?

The U.S. Food and Drug Administration (FDA) defines an OTC Monograph Drug Facility as a facility that manufactures or processes the finished dosage form of a nonprescription, over-the-counter drug that may be marketed without an approved drug application (known as an OTC monograph drug). This also includes “finished dosage form manufacturer facilities in contractual relationships with the sponsor of one or more OTC monograph.”

Additionally, OTC contract manufacturing organizations (CMOs) are OTC drug facilities where neither the owner of the facility nor his or her affiliates sell the OTC drug to retailers, wholesalers, or consumers in the US.

According to FDA, businesses whose manufacturing or processing activities include only the following are not considered OTC Monograph Drug facilities: “production of clinical research supplies; testing; or placement of outer packaging on packages containing multiple products, for such purposes as creating multipacks, when each monograph drug contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging.”

How much are the fees?

FDA has not yet stated the cost of facility fees. However, the Administration has stated that the fee for CMOs will be two-thirds the cost of the total facility fee.  Facility fees will be due 45 days after the FY 2021 fee amounts are published in the Federal Register.

How to Prepare

FDA will assess fees for a drug establishment based on the business operation qualifiers selected in the establishment’s registration.  Registered drug establishments should review the qualifiers selected in their registrations and ensure they accurate in advance of FY 2021, which begins October 1, 2020.

Assistance with OMUFA and other OTC Requirements

Registrar Corp is committed to providing you with high quality regulatory assistance. Contact us if you need help determining how FDA’s new fees affect your facility.

Registrar Corp can register your OTC Monograph Facility with FDA, list your OTC drugs, serve as your Adverse Event Contact, and more. To learn more about Registrar Corp’s OTC Monograph Drug services, contact us at  +1-757-224-0177 or email us at [email protected].

FSSC Approves Registrar Corp’s Online Training Courses

On July 6, two of Registrar Corp’s 100% online FSSC 22000 training courses were approved by the FSSC 22000 food safety certification program:

Registrar Corp is an FSSC 22000 licensed Training Organization. FSSC 22000 Training Organizations are monitored under the FSSC 22000 Integrity Program. The program and course approval verifies that Registrar Corp’s trainings meet the FSSC 22000 requirements. Registrar Corp’s training programs are the first completely online courses to be approved by FSSC 22000.

The FSSC 22000 food safety certification program is recognized by the Global Food Safety Initiative (GFSI), an organization developed to promote international food safety standards. While GFSI is not a food safety scheme itself, it sets standards for the schemes. Buyers around the globe often require or prefer food suppliers to be certified under a GFSI-recognized scheme.

Be confident in your preparation with Registrar Corp’s FSSC 22000 approved courses. Registrar Corp’s training courses provide a step by step guide through the process to become certified. After completing Registrar Corp’s training, facilities will have the knowledge needed to prepare their facility for a Certification Body audit.

Click here to learn more about Registrar Corp’s FSSC 22000 training courses.  If you have questions about GFSI, FSSC certification, or which course would be best for you, contact Registrar Corp’s training department at [email protected] or by calling +1-757-224-0177 (option 5).

 

About Registrar Corp

Registrar Corp is the leading provider of U.S. Food and Drug Administration (FDA) compliance services. Since opening its Hampton, Virginia headquarters in 2003, Registrar Corp has expanded to 20 worldwide offices and has aided more than 50,000 companies across 160 countries. In March 2020, Registrar Corp acquired Vinca, LLC (dba ‘www.22000-Tools.com’) and added Vinca’s array of online food safety courses to their comprehensive suite of FDA compliance services.

 

How COVID-19 is affecting the food industry

Registrar Corp recognizes that there are many concerns and questions about how COVID is affecting the food industry.  In this article we will discuss how the pandemic is affecting food safety and supply.

COVID-19 Is Not a Food Borne Illness

One of the top concerns surrounding the food industry during COVID-19 has been whether the virus can spread through food.  The Center for Disease Control (CDC) has stated that, “currently, there is no evidence to support transmission of COVID-19 associated with food.”

Food Products are in High Demand

During the pandemic, the demand for certain food items is higher than ever. Retailers across the United States are selling out of items such as beans, eggs, and rice. Even alcohol is at an increased demand. Additionally, canned goods and packaged foods like noodles are also selling larger quantities due to their long shelf lives and their status as staples in many dishes. As a result, brands like General Mills and Campbell Soup reported more than a 60 percent increase in food sales over a four week period.

“Almost all our plants are running at capacity,” John Church, General Mills’ chief supply chain officer, said in an interview with New York Times. Despite this, retailers struggle to keep canned goods on their selves and many have set purchasing limits.  Due to the high demand, the need for continued importation of food is likely to remain high as well.  Exporters of shelf stable canned goods seeking to help supply the demand must note that the U.S. Food and Drug Administration (FDA) requires manufacturers to obtain a Food Canning Establishment (FCE) registration to market goods in the United States.

Products that are viewed as healthy are also seeing an increase in demand. The price of avocados has continued to rise with the increased demand for them. In general, the US is seeing a large amount of produce sales. This increase is likely the result of consumers aiming to improve their immune systems in light of the virus.

Not all food products are seeing this increase in demand; luxury food sales have been on the decline. Spending trends have shown that as people are working less because of COVID-19, they are also spending less and limiting purchases to necessities. One industry expert pointed out that in-store shoppers are “getting in and out quickly buying staples such as pasta, beans, flour, rice, bottled sauces, jarred vegetables, and tinned seafood. For the most part, impulse purchases are dead.” When things return to normal, consumers will likely return to exploring and impulse buying. When the COVID-19 pandemic slows, more consumers may revisit purchasing luxury and specialty foods, especially during the holiday season.

Supply Chains Are Expanding

COVID-19 has pushed some retailers to source from additional food suppliers for high demand food items as their existing suppliers find challenges in meeting consumer demands.  When asked about her experience with supply chain issues, the Vice President for a California market chain stated“… in the beginning we did have a couple of issues with staple items like pasta and beans but we moved through that shortage quickly and were able to find different sources for those items.” Now could be an excellent time to enter new markets if you manufacture any of these high demand items.

The US meat packing industry in particular is struggling to keep production lines running with recent closures of large facilities. This creates an opportunity for additional meat imports into the US market.

Long Term Effects of COVID-19 on the Food Industry

Experts are uncertain what the future holds but suggest that, “some of these trends could be here to stay. Now that some people have gone back to packaged foods, they may be surprised to see the quality improvements for these products and keep buying them even in the post-quarantine world. Cooking more at home might also continue well after the lockdowns end.”

In spite of this pandemic, people must eat, and there is plenty of opportunity in the U.S. supply chain for food manufacturers. It is important for facilities to keep their FDA registration valid and up to date. Even if your shipments are currently slowed, you should be prepared for the inevitable bounce-back as U.S. inventories need to be replenished.

Though other FDA-regulated industries have seen change in regulation during COVID, FDA is regulating food the same. Facilities still need to ensure that they are registered and properly labeling their products. Registrar Corp is open and available to help you register with the FDA during these uncertain times. Let Registrar Corp’s trained experts guide you through the registration process by contacting us today. Call us at  +1-757-224-0177 or send an email to [email protected].