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Tea Business Owners: Beware of Top Five FDA Inspection Violations

The U.S. Food and Drug Administration's data depicts the frequency of violations found during FDA food facility inspections. The following are the top five violations cited by FDA inspectors in the fourth quarter FY 2020. Hula Consulting provides this list for Tea Business Owners for proactive readiness and urges them to seek assistance for their particular needs.


1. FSVP Development

Under the Food Safety Modernization Act (FSMA), the FDA requires most food importers to develop and maintain Foreign Supplier Verification Programs (FSVPs) for their suppliers, which helps ensure that suppliers remain #FDAcompliant and produce goods in a safe manner.

During FSVP inspections, the FDA expects importers to present complete FSVPs that adequately state the food safety of suppliers. For the third year, the failure to develop an FSVP was the top cited inspection violation. In FY 2020, 514 facilities were cited for this failure. Although physical food facility inspections were halted in 2020 due to the COVID-19 pandemic, the FDA continued with remote #FSVPinspections. These citations increased by 51% from 2019.


2. Hazard Analysis

The FDA requires most food facilities to identify potential hazards that may occur at their facility in addition to establishing their preventive controls. In 2020, the FDA cited 104 cases where facilities failed to provide an adequate hazard analysis.

These hazards can vary, and many tea and coffee companies may not have any to report. If you're unsure, contact us for clarification.

3. Pest Control

The FDA searches for signs of current and potential pest infestations during their facility inspections. Additionally, the FDA seeks for signs of misusing pesticides in a way that could cause potential food contamination and failure to prevent pests within their food facility. The FDA cited 98 facilities for these types of failures.

4. Manufacturing Controls

The FDA requires facilities to provide controlled environments when handling food products to avoid potential health risks to consumers. In 2020, 95 of these food facility citations were given, which indicate that a facility did not conduct operations under conditions that would minimize chances for potential microorganism growth, allergen cross contamination, or contamination and deterioration of food. Ensuring these controls is imperative for your business and for the safety of your consumers.

5. Personnel

We cannot forget your personnel! These citation types include failures to address hygiene issues or other good manufacturing practices in relation to your employees handling food products. The FDA issued 87 of these citations.


Feeling a Little Freaked Out? If you feel unprepared for an upcoming FDA inspection, you'll need an expert like Hula Consulting on your team.


Whether you simply have a few questions, seek some assistance with compiling your documents, or a complete virtually conducted mock inspection (#gapaudit) visit to your facility, Hula Consulting can help. Hula Consulting's professional services will provide you with a full report complete with the necessary corrections necessary to comply with FDA regulations. Contact us today at 561.600.7025 or scott@hulaconsulting.com. We look forward to helping you with your business!

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