FSMA Compliance: Are You Ready?

How PCQIServices.com Helps FDA-Regulated Facilities Stay Inspection-Ready

The U.S. Food and Drug Administration (FDA) has intensified its oversight of food facilities under the Food Safety Modernization Act (FSMA)—a sweeping reform designed to shift the focus from reaction to prevention. For FDA-regulated entities, the message is clear: compliance is not optional.

One of the most critical aspects of FSMA is 21 CFR §117.1, which outlines the Preventive Controls for Human Food Rule. This regulation requires food facilities to implement robust food safety systems that proactively identify and control potential hazards—before they result in adulterated or unsafe products entering the supply chain.

So, the real question is: Is your facility FSMA compliant?

Why 21 CFR §117.1 Matters

21 CFR §117.1 mandates that covered food facilities must develop and maintain a Food Safety Plan that includes:

• Hazard analysis
• Preventive controls
• Monitoring procedures
• Corrective actions
• Verification activities
• Recordkeeping

This rule applies to most food facilities registered with the FDA and is essential in preventing issues such as microbial contamination, allergen mislabeling, and sanitation failures—all of which could result in FDA Warning Letters, product recalls, or detentions at import.

Adulteration Is a Top FDA Concern

Food adulteration remains one of the leading reasons for FDA enforcement actions. Whether unintentional or due to poor sanitation practices, adulterated products pose a threat to public health and can devastate your brand’s reputation and operations. A comprehensive Preventive Controls program, guided by a certified Preventive Controls Qualified Individual (PCQI), is the most effective way to prevent such risks and demonstrate proactive compliance during FDA inspections.

How PCQIServices.com Supports Your FSMA Readiness

At PCQIServices.com, we provide end-to-end compliance solutions to help your food facility achieve and maintain FSMA compliance. Our services are led by certified PCQIs and designed to align fully with 21 CFR §117.1 and other related FDA regulations.

Our support includes:

✅ PCQI-Led Assessments

We perform a full review of your current food safety systems and identify gaps relative to FSMA requirements.

✅ Sanitary Operations Audits

We evaluate facility sanitation controls and environmental monitoring procedures to mitigate cross-contamination and adulteration risks.

✅ Risk Control Programs

We help you implement preventive controls tailored to your products, processes, and facility setup—whether you handle human food, dietary supplements, or animal feed.

✅ FDA Inspection Readiness

Our compliance documentation, verification plans, and monitoring logs are built to withstand regulatory scrutiny and ensure your facility is always audit-ready.

Compliance That Lasts

FSMA is not a one-time checkbox—it’s an ongoing commitment to food safety excellence. Whether you're a startup food brand, an established processor, or an international supplier entering the U.S. market, PCQIServices.com provides the tools and expertise to help you stay ahead of evolving FDA regulations.

Get Started Today

Don’t wait for an FDA inspection to expose compliance gaps. Partner with PCQIServices.com to build a preventive, risk-based food safety program that protects your customers—and your business. Visit PCQIServices.com to schedule a compliance consultation or request a custom Preventive Controls support package.