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FDA FY 2018 Inspection Observations: 278 U.S. Importers Cited for FSVP Violations

The U.S. Food and Drug Administration (FDA) recently released its Fiscal Year (FY) 2018 Inspection Observation Data.  The data aggregates violations documented during FDA inspections from October 2017 through September 2018.  During this period, FDA cited 278 U.S. importers of food and beverages for not developing Foreign Supplier Verification Programs (FSVP), making it the most frequent inspection violation of FY 2018. This article provides an overview of what these FSVP violations mean for industry as well as the other five most commonly cited violations this year.

FSVP Violations

As of March 19, 2018, most food importers are required to develop FSVPs for their foreign suppliers and monitor their suppliers’ FDA compliance statuses.  After the first FSVP deadline in May 2017, FDA cited 108 importers for not developing FSVPs during FY 2017 inspections.  FSVP’s prominence on this year’s list of violations suggests that FDA is regularly inspecting importers for compliance.

Importers should be prepared for FDA to examine their FSVP records and verify that they are properly monitoring their suppliers.  Non-compliance with FSVP regulations may result in civil penalties.

Registrar Corp’s Qualified Individuals can assist by developing your FSVPs or reviewing your current programs for compliance.  Additionally, Registrar Corp’s FDA Compliance Monitor simplifies supplier monitoring by continuously tracking your suppliers’ FDA compliance and issuing monthly reports that support FSVP documentation requirements.  Schedule a demo to learn more.

Top Five Food Facility Violations

FDA cited registered food facilities for a variety of food safety issues this year.  Below are the top five most common food safety violations discovered by FDA in FY 2018:

  • Sanitation Monitoring – FDA cited 188 facilities for not properly monitoring sanitation conditions and practices with sufficient frequency. Facilities are required to monitor aspects such as the safety of water coming into contact with food or food contact surfaces, prevention of cross-contamination, and maintenance of hygiene facilities.
  • Pest Control – FDA cited 183 facilities for not properly excluding pests from potentially contaminating food.
  • Manufacturing, Processing, Packing, and Holding Controls – FDA cited 175 facilities for not implementing proper controls to mitigate the risk of food hazards, such as growth of microorganisms, allergen cross-contact, and contamination of food.
  • Sanitary Operations and Plant Maintenance – FDA cited 167 facilities for either not maintaining cleanliness of their facilities or not keeping them in good repair.
  • Personnel – FDA cited 161 facilities for not taking reasonable measures and precautions related to personnel. These may include failing to address hygiene and cleanliness of staff working in direct contact with food.

Food facilities should ensure compliance with the above and other good manufacturing practices.  Food safety violations discovered during an inspection may result in FDA enforcement such as Warning Letters, Import Refusals, or Import Alerts.  These compliance issues can damage a brand’s reputation and often influence the buying decisions of purchasers.

To prepare your facility for an FDA inspection, Registrar Corp can dispatch a Food Safety Specialist to conduct a Mock FDA Inspection.  Our experts will identify potential food safety issues and educate facility staff on FDA expectations during an inspection.

Preventive Controls Violations

While no individual violation of the FDA Preventive Controls rules made it to the top of the list, violations of Preventive Controls requirements in FY 2018 total 396 when combined.  These include issues such as not having a Hazard Analysis and Risk-Based Preventive Controls (HARPC) Plan, not identifying a hazard that requires a preventive control in a HARPC Plan, not utilizing a Preventive Controls Qualified Individual (PCQI) to prepare or oversee a HARPC Plan, not implementing adequate procedures for monitoring sanitation or allergen controls, and more.

The deadlines for most facilities to comply with Preventive Controls requirements have passed, and these violations are evidence that FDA is actively inspecting facilities for compliance with the rules.  Facilities should familiarize themselves with Preventive Controls regulations to ensure they are properly accounting for all HARPC requirements and any differences from other food safety systems they may be using to draft their HARPC plans.

Alternatively, Registrar Corp’s PCQI Food Safety Specialists can assist by developing a HARPC Plan for your facility or reviewing your current plan for compliance.

For assistance with FDA food safety regulations, call Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.