August 22, 2017

FSMA Compliance Countdown: Tips for Inspection Preparation

Whether you are a Private Equity firm planning to invest in a mid-market Food Manufacturer, or a Food Manufacturer working towards regulatory compliance, you undoubtedly know that the Food and Drug Administration’s (FDA) Food Safety Modernization Act (also known as FSMA) compliance date of September 18, 2017 is around the corner.

Despite months of meticulous preparation, you may still be questioning if your company is fully compliant with the Human Food Preventive Controls Rule. Does your team know what to expect during its first FSMA inspection?

At the recent 2017 Annual International Association for Food Protection Conference, the FDA shared an inside perspective on FSMA enforcement. Following is a summary of that perspective for your review.

FDA’s Enforcement Strategy

FDA intends to use an “educate while we regulate” collaborative approach during the initial enforcement of the new FSMA laws. But what does that really mean for industry?

Education Prior To and During Regulation – FDA continues to offer industry opportunities to learn alongside inspectors during the development of guidance documents, collaborative FSMA trainings, and a modified approach to facility inspections.

Group Inspections – FDA is utilizing industry experts and providing hands-on field experience during inspections to train FDA and State Inspectors. For this reason, you may have multiple inspectors or agencies involved in your next regulatory inspection.

Regulatory Shift Towards “Systems-Based” Inspections – Modified inspections are focused on program development and record review, rather than observational based inspections.

Open-Ended Questions and Discussions – Inspectors are posing open-ended questions during facility inspections to facilitate discussions regarding what actions your company is taking to meet new requirements. This approach is providing regulatory inspectors deeper insight into different operational practices, as well as giving companies a chance to explain and/or defend their food safety programs.

Streamlined Corporate Program Review – FDA is conducting corporate level or desktop reviews of companies’ supply chain management and recall plans prior to visiting individual facilities. Be prepared for the FDA to request and review your documentation remotely.

FDA’s goal is not to prescribe food protection policies; rather to focus on collaborating with your teams to assess relevant hazards and to reach agreement on the best preventive actions to implement at your facilities.

What Should Small & Medium Sized Businesses Expect?

Inspections will focus on compliance to modified Good Manufacturing Practices (GMPs) with a broader overview of your company’s Food Safety Plan.

On-site inspections and record review under FSMA are centered around four key areas:

1. GMPs and Food Safety Plan – Inspectors will conduct reviews of your modified GMPs and Food Safety Plan.

2. Employee Training Records – Inspectors will review training records and may hold on-floor interviews with your employees to ensure they have appropriate knowledge of food hygiene and food safety practices.

3. Sanitation Procedures and Records –Sanitation program and verification activities may be reviewed to assess the adequacy of cleaning processes.

4. Product Waste-Stream Review – Product waste streams will be reviewed to ensure that handling of food by-products used for animal feed is complaint with the Animal Food GMPs Rule and is protected from contamination.

Possibly the most daunting part of the new inspection process is the review of the Food Safety Plan. You should be prepared to discuss the hazard assessment and driving factors behind the selection of your Preventive Controls and respective monitoring, verification, and validation activities.

One way that you can prepare for this discussion is to review the “Draft Guidance for Industry on the Hazard Analysis and Risk-Based Preventive Controls for Human Food”.  FDA inspectors are utilizing this document during inspections to understand known product-specific hazards and suggesting best practices to mitigate those risks.

In addition, FDA may conduct extensive pathogen testing within your facility (informally known as a “Swab-A-Thon”). It is important that your company develop written policies on how to handle an inspection, including rules on photos, assessible records, and sample collection processes.

If an inspector concludes that preventive controls are inadequate and may result in a public adverse event, a full scope inspection may be initiated. This full scope inspection will include detailed reviews of your modernized GMPs and Preventive Controls programs, including but not limited to; allergen, sanitation, environmental monitoring, and process control programs.

How Have Inspection Outcomes Changed?

Completion of voluntary corrections of minor violations prior to the close of inspection is encouraged to reduce the use of regulatory-required corrections, through 483s or Warning Letters.

FDA will rank violations based on the following categories:

Minor – deficiencies with no little-to-no food safety risk
Major – deficiencies likely to result in food safety risk or may indicate system failure
Critical – deficiencies that are an imminent public health danger

Remember, being proactive in anticipating the inspector’s questions and demonstrating willingness to collaborate with the inspector to improve compliance is key to a successful FSMA inspection.

Additional information regarding FSMA and the GMP and Preventive Controls for Human Food Rule please see the following resources:

FSMA Guide for Private Equity Investors– Download PDF by TriVista

Technical Assistance Network – Q&A with FDA Information Specialist and subject matter experts
Draft Guidance for Industry on the Hazard Analysis and Risk-Based Preventive Controls for Human Food -FDA published draft guidance document

Food Safety Plan Builder – Software to help organize and develop FSMA required Food Safety Plan

TriVista’s Food Safety & Regulatory Compliance Practice has a disciplined Food Safety Due Diligence process that is developed exclusively for middle-market, Private Equity-financed manufacturing and distribution companies.  To learn more about our Practice click here or call us at  949.218.4830


TriVista is a global management consulting firm that specializes in evaluating and improving middle-market, private equity-financed manufacturing and distribution companies.

TriVista’s global team is comprised of professionals with extensive industry, functional, management and advisory experience who have implemented operational best practices at some of the world’s most respected companies. Leveraging this experience—as well as TriVista’s structured, fact-based approach to operational improvement—they have helped clients minimize risk, enhance customer satisfaction and margins, and reduce working capital.

The firm is headquartered in Aliso Viejo, CA with offices through North America, Europe and Asia.


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