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Warning Letters for Preventive Controls and FSVP Violations Issued by FDA

The Food Safety Modernization Act (FSMA) states that most food facilities operating in or exporting to the United States are required to have a Food Safety Plan following the Hazard Analysis and Risk Based Preventive Controls (HARPC) methods.


This Act also requires U.S. importers to have a Foreign Supplier Verification Program (FSVP) for all imported food products or ingredients like those found in teas and herbal tisanes. Many of the compliance deadlines for these rules have passed and the U.S. Food and Drug Administration (FDA) has been increasing verification of these rules during facility inspections. You should have your Food Safety Plan and FSVP in place now to avoid any compliance issues with the FDA. 


Failure to develop an FSVP was the most frequently cited violation during the FDA's facility inspections in 2018. The FDA has continued to enforce these rules in 2019, issuing several warning letters to companies for FSMA violations.



FSVP Violations

Tea companies that import teas, herbs, packaging, etc. are required to verify and approve that their overseas suppliers' products meet the food safety standards of the United States. Importers must establish and follow written procedures to import products only from approved suppliers. This is includes all countries outside the US, even Canada and Mexico.


Importers are responsible for confirming that the products they import follow applicable FDA regulations, such as Preventive Controls rules or Current Good Manufacturing Practices. These need to be developed for every individual product that is imported. Suppliers must be re-evaluated at least once every three years and/or when a food safety issue occurs


According to the FDA, “[FDA] will take more steps to ensure compliance with FSVP, including reinspecting importers that had deficiencies in previous inspections and by acting immediately when FSVP deficiencies are found that pose an imminent public health risk”.


If a warning letter is received for FSVP violations, the recipients are required to respond to the letter within 15 days with corrections to the violations. FDA may subject the importer to Import Alert #99-41, Detention without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the FSVP Regulation. FDA is taking FSVP enforcement seriously, and importers should ensure they have compliant FSVPs in place immediately.


Compliant Food Safety Plan & Execution

For some facilities, not having a Food Safety Plan is still an issue. In a warning letter sent to a company in violation earlier this year, the FDA notes the company has been required to develop a Food Safety Plan since September 18, 2017. It's highly likely that The FDA will check to see if your facility has a Food Safety Plan in place. A complete Food Safety Plan identifies all potential biological, chemical (including radiological), and physical hazards to a food’s production and then establishes controls to contain or eliminate these hazards. The Food Safety Plan must be written by a training Preventive Control Qualified Individual (PCQI) that is either on staff or as a consultant.


It is necessary to be very thorough when creating your Food Safety Plan and take care not to leave out a component of the plan or to not identify all of the potential hazards in a facility and establish controls for those hazards. Facilities are also required to maintain written records on monitoring, corrective actions, and verification of the controls. Failure to adhere to any of these or other requirements of a Food Safety Plan can result in a citation or warning letter.


Once your facility’s Food Safety Plan is written and in place, it must be continually executed and updated. Implementing your plan as part of your daily standard operating procedures with reevaluations to the plan at least once every three years will help keep you on a path for success. Additionally, noting if any issues arise and proper employee training is needed for all employees to demonstrate their responsibilities towards executing the plan. Employee training must take place upon hire, annually thereafter, and as needed based on job performance. The FDA may check to ensure your employees are executing your Food Safety Plan even if it is written; including interviewing your employees. Failure to actually execute the plan can result in a warning letter or other regulatory action.


Food Safety Plan & FSVP Compliance Assistance

There's no need to feel overwhelmed with your #compliance and #regulatory business plans. Hula Consulting is here to help assist you with your Food Safety Plan, ensuring #FDA compliance and help with your #FSVP and sourcing compliant ingredients for your #teas and coffees. Contact us today at 561.600.7025 or send an inquiry to scott@hulaconsulting.com. We look forward to helping you with your business!

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