Under the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) received a legislative mandate to require comprehensive, prevention-based controls across the U.S. human and animal food supply to prevent foodborne illnesses. This is the most sweeping reform to food safety laws in more than 70 years. The purpose of this mandate is to hold the human and animal food industries accountable for the production of safe food.
Armstrong Teasdale’s FSMA Compliance Review Team offers a tailored solution to each client by providing individualized program audits. These reviews aim to ensure that your company’s FSMA compliance program adheres to the extensive regulatory requirements implemented by FDA.
Our FSMA Compliance Review begins with a determination of the FSMA requirements that apply to your organization. This includes a review of any exemptions or delay in implementation deadlines based on numerous factors outlined by FDA in guidance and regulation.
We then conduct a documentation review of your organization’s current policies and procedures that address the following areas impacted by FSMA:
- Sanitary transportation and holding of human or animal food;
- Preventative controls for human or animal food;
- Intentional adulteration risks;
- Foreign supplier verification procedures (“FSVPs”); and
- Produce safety procedures.
Based on this review, our FSMA Compliance Review Team will determine whether your organization’s policies and procedures can be easily updated to accommodate FSMA requirements, or if they require a greater overhaul in order to comply. Regardless of the steps necessary to comply, we offer cost management solutions and business strategies to minimize disruption to your supply chain and maximize efficiency and profits.
Deploying the FSMA Compliance Review typically involves an analysis of other areas impacted by FSMA requirements. For example, we also take into consideration your employee training procedures, product tracing programs, record retention policies, recall procedures, and import/export procedures, when applicable. Additionally, we conduct an extensive review of your business partners (domestic and international), contractual relationships, liability gaps, internal controls, container and cargo security, and physical security. We also analyze your organization’s general FDA compliance obligations and determine your risk for enforcement actions/monetary penalties for breach of FDA laws and regulations. Our Review Team performs these tasks in a manner consistent with existing company processes.
Finally, we might conduct a site visit that entails interviews with all key stakeholders (such as your regulatory/compliance team, and other participants in your supply chain) that impact FSMA compliance, if necessary. The process culminates with a detailed attorney-client privileged report that identifies the required FSMA changes, applicable exemptions, suggests substantive and procedural improvements, and develops a plan of action for bringing your organization into compliance within FDA mandated deadlines.
Our attorneys have significant experience advising various industries on the ever changing laws and FDA regulations, and specifically those regulatory requirements stemming from FSMA. Team members serve as close advisors, guiding companies of all sizes through the regulatory framework, from startups to Fortune 100 companies. Our ultimate goal is to help our clients grow market share while cost-effectively navigating the growing regulatory burdens and legal actions that impact their specific industry.