• Hula Consulting

FDA INSPECTION VIOLATIONS ON THE RISE

The U.S. Food and Drug Administration released its Inspection Observation Data for the Fiscal Year 2019 (Oct 2018 - Sept 2019) to note cited violations during facility inspections. Last year’s most commonly cited violation during food facility inspections was failing to develop a Foreign Supplier Verification Program (FSVP), with a total of 298 violations.


Since 298 violations are no easy cup of tea (pun intended), we are happy to provide some clarity in what the FDA expects when conducting an FSVP inspection, as well as some other commonly cited food facility violations.


FSVP Violations

Under the Food Safety Modernization Act (FSMA), most food importers are required to develop and maintain FSVPs for their foreign suppliers. This requires importers to perform certain activities to ensure their suppliers are FDA compliant and producing goods in a safe and acceptable manner. If you are importing teas, herbs, packaging, or having your product produced outside the US you are required to have FSVPs in place.


Many of the FSVP compliance deadlines have already passed and should be active in applicable importers' businesses, as the FDA expects the presentation of the FSVPs upon inspection. In 2017, the FDA cited just 108 importers for failing to develop an FSVP, and that number skyrocketed to 298 last year.


Food Safety Violations

The increase in FSVP violations relating to food safety and good manufacturing practices in addition to the FSMA-related warning letters show a consistent increase in FSMA enforcement from the FDA. Here are the five most common violations cited in 2019:


  • Personnel (21 CFR 117.10)- This violation is for failing to take reasonable measures and precautions related to personnel practices - to include failing to address hygiene issues and employees handling food products. There were 226 citations.

  • Pest Control (21 CFR 117.35(c))- The FDA cited 222 facilities for not excluding pests from their facility or for utilizing pesticides in unlawful manners.

  • Sanitation Monitoring (21 CFR 120.6))- A 195 citations issued for a failure to monitor sanitation conditions and implement good manufacturing practices, which can range from failure to use clean water for food production, unclean food contact surfaces, cross-contamination risks, and other poor sanitation practices.

  • Sanitary Operations and Plant Maintenance (21 CFR 117.35(a))- 193 violations include failing to maintain the plant in a clean and sanitary condition or keeping the plant in good repair.

  • HACCP Plan Implementation (21 CFR 123.6(c))- FDA cites 182 facilities for failing to implement either the monitoring, recordkeeping, or verification procedures listed on their HACCP Plans. There were over 500+ other citations relating to HACCP.


What Do I Avoid A Citation?

The best plan to avoid a Citation is Preparation! When FDA inspects a food facility, the agent checks for compliance with current good manufacturing practices and any other applicable food safety regulations. Failure to comply can result in warning letters, citations, or detentions.


If you feel unprepared for an upcoming FDA inspection, you'll need an expert on your team - and we can help! Hula Consulting can help with your questions and documents, as well as assist in a mock-inspection (gap audit) visit to your facility and give you a detailed report on what is necessary to correct in order to pass an FDA inspection.


If you don't have the proper plans in place, citations happen. Not sure what to do? Hula Consulting is here to help assist you with your Food Safety Verification 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!

SUBSCRIBE VIA EMAIL