State Level Violation Trends – Colorado Department of Public Health & Environment – State’s Hemp Regulatory Authority

First, we will look into trending violations at Colorado’s state level hemp regulatory authority. The Colorado Department of Public Health and Environment (CDPHE) currently inspects hemp manufacturing facilities. These manufacturing facilities produce wholesale food products, dietary supplements and/or cosmetic products. CDPHE published their winter newsletter to include trending violations at industrial hemp facilities. Their trends reveal violations observed from the last two years – 2020 & 2021. CDPHE’s most common written violations at hemp facilities include:

Hand Sinks: No easily accessible hand sinks in the production areas & no hand sinks located in the facility.

Bathroom Doors: Bathrooms lack self-closing doors or that lead into the production room.

Food Contact Surfaces: Nonfood grade buckets used to store ingredients and/or finished products.

Sanitation: No sanitizer test strips.

Lights: Lights above production areas are not protected from breakage.

CDPHE’s top 5 most common violations at hemp manufacturing facilities involve requiring facility updates and human errors. Human error could arise from multiple systemic issues: lack of quality management system and written instructions, lack of education, or lack of employee buy-in which is needed to create a food safety culture at any facility. All violations have one thing in common: the errors could result in product contamination.

Federal Level Violation Trends – The Food & Drug Administration – Food Facility Inspection Violation Trends

Now onto looking deeper into federal level top 5 violation trends. The FDA’s 2020 food facility violation trends are collected from FDA’s Inspection Observation Data report. Although the FDA halted many federal inspections due to the pandemic, there are still many data points we can use to better understand their most common violations. Keep in mind the FDA does not regulate THC cannabis or hemp production establishments. However, the federal inspection results may provide further insight into how the cannabis/hemp businesses will be audited if the FDA decides to regulate the industry. The FDA’s most common violations are grouped into categories rather than specific violations:

Lack of Foreign Supplier Verification Program (FSVP) Development
*The FDA requires most food importers to develop and maintain a FSVP for all foreign suppliers. This helps ensure foreign suppliers are held to FDA’s standard prior to entry into the United States.

Failure to Provide Adequate Hazard Analysis
*Identifying hazards (biological, chemical, or physical) establishes a facility’s preventive controls to maintain food safety protocols.

Pest Control
*FDA cited facilities for failure to prevent pests within the facility or for misusing pesticides that could contaminate food

Manufacturing Controls
*Manufacturing, processing, packing and holding controls that would minimize contamination of food.

Personnel
*This may include failing to address employee hygiene or improperly handling food products.

FDA’s top 5 most common violations at food manufacturing facilities involve a lack of required program development, prevention of contamination from pests/pesticides, deficient manufacturing controls, and personnel violations. As with CDPHE’s common violations, all violations have one thing in common: the errors could result in product contamination.

How Can We Use These Violation Trends to Our Advantage?

Violations are documented to prevent product contamination and ultimately to safeguard consumers. Correcting violations protects your company from liability issues. Following violation trends provide valuable information to regulated companies and gives us a chance to learn from other’s mistakes. Understanding the most common violations allows companies to best prepare for future audits. Preparing for audits is complex because regulatory compliance includes many aspects including: a compliant physical facility (sinks, doors, floors/ walls/ ceiling), robust quality management system (policies, SOPs, work instructions), commitment from upper management, creating & sustaining a food safety culture, and a strong education system. One way to ensure compliance during regulatory audits is to adopt a Quality Management System (QMS). Utilizing a QMS gives your company a competitive edge by ensuring safe products to customers. Allay Consulting’s compliance services works one-on-one with your company to create a realistic Quality Management System that is unique to your company.

Contact Allay Consulting to learn more about implementing a QMS system, written documentation, facility compliance, and employee education!