AUDIT

ESI provides comprehensive Auditing services encompassing: laws, international regulations, document reviews, or product specifications. This includes inspections related to country-specific mandatory regulations, such as detailed Pre-Audit FDA assessments for companies of all sizes, including FSMA compliance assessments, FSMA training audits, audits for Canadian SFCR regulations, UK regulations, and more.

Audit and inspection services are carried out upon industry request or on behalf of organizations, retailers, and foreign clients:

  • To evaluate and qualify potential suppliers.

  • As part of supply chain surveillance programs.

  • To verify compliance with product specifications, regulations, mandatory and/or voluntary international standards, and more.

UNITED STATES - FSMA TRAINING AUDIT

You can turn to us when you need an AUDIT for compliance verification in the following areas:

  • Current Good Manufacturing Practices (CGMPs)

  • Food Safety Modernization Act (FSMA) and specific rules

  • Foreign Supplier Verification Programs (FSVP)

  • To identify improvement actions and achieve compliance with applicable regulatory requirements.

  • Good Agricultural Practices (GAP)

  • Good Laboratory Practices (GLP)

  • Hazard Analysis and Critical Control Points (HACCP)

  • Low-Acid Canned Food (LACF)

  • US HACCP

The Food Safety Modernization Act (FSMA) by the United States Food and Drug Administration (FDA) is considered the most significant reform of American food safety regulations in the past 70 years. Unlike previous food safety regulations, FSMA focuses on risk prevention and requires food industry operators to ensure safe practices throughout the entire supply chain, from production to distribution.

Our FSMA Compliance Training Audit service actively assists companies in complying with obligations derived from the Preventive Controls for Human Food Regulation. The Audit is conducted by qualified specialists with years of experience who are well-versed in the specific food-related US regulations.

ESI auditors are recognized regulatory auditors who conduct GMP/FSMA audits, contract manufacturing audits, and laboratory facility audits to assess compliance with applicable FDA regulatory requirements, as well as best practices. We perform gap assessments to inform you of necessary improvements to achieve full FDA regulatory compliance.

The goal of the FSMA Training Audit is to assess your company’s status and prepare it for an FDA audit. Our assessments are thorough and comprehensive. You will receive a detailed report outlining your current level of compliance in both practical and documentation aspects, along with our recommendations for addressing identified deficiencies.

FIND OUT SUPPORT FOR AN OFFICIAL FDA INSPECTION

An FDA inspection aims to verify that the processes involved in producing food products within the facility comply with FSMA regulations and the applicable rules for the exported product. These inspections are typically pre-announced, allowing time to ensure that implemented procedures align with US authorities’ requirements.

If you have received an inspection notice from the FDA you can ask for our support: the ESI technical team with decades of experience on the FSMA regulation has supported over 1000 companies over the years during FDA inspections with 100% success.


Here’s how we can be your ideal ally:

1. FSMA GAP ANALYSIS REPORT
Our Documentary Gap Analysis service for an FDA inspection helps the food industry evaluate the documentation required for the specific FSMA regulation.
The documentation evaluated includes: Food Safety Plan, Food Defense, Recall Plan, CGmp, procedures, processes that the company uses as required by FSMA regulations, etc. The Report generated by the Gap Analysis aims to identify gaps or inefficiencies in the evaluated documentation.
It is delivered remotely and carried out by a technical team of qualified auditors.

2. FSMA PLAN COMPLIANCE

Our FSMA Gap Analysis aims to identify gaps, inconsistencies and areas for improvement in the FSMA documentation. Once these points have been analyzed and discussed, our expert technical team, first qualified and recognized as a pillar in compliance with North American regulations and specifically for FSMA regulations, will intervene to ensure that the documentation is complete and compliant with US regulations. This may include the implementation of new documents such as: Food Safety Plan, Food Defense Plan, Recall Plan, etc or the revision of existing ones, always ensuring adherence and compliance with US regulations.

3. PRE-AUDIT FDA

Our FDA FSMA Pre Audit service is the key to ensuring that the company is assessed for compliance with the relevant American regulations for your products in view of the U.S. Inspection. FDA. In fact, the ESI technical team, a recognized leader on North American regulations, with over 1000 audits carried out on FSMA regulations at a national and international level, will examine your food production chain, analyzing the processes that will be subject to inspection by FDA inspectors. Upon completion, you will receive a detailed report containing recommendations, corrective measures and a percentage assessment of both field and documentary compliance.

4. SUPPORT DURING FDA INSPECTION

When the FDA visits your facility, it is a crucial event that can be stressful for all roles involved, especially the PCQI and company owner. In an environment where regulatory compliance and compliance are key, it is essential to have a trusted partner. That's why you can rely on ESI's Technical Team. We actively support you throughout the entire duration of the visit: we help you manage and respond effectively to inspectors' requests, ensuring not only peace of mind during the process, but also the optimal outcome of the inspection.

REMOTE AUDIT

We were the first globally to utilize augmented reality (Smart Glasses developed by Google and Microsoft) for conducting remote audits during inspections mandated by FSIS – the USDA’s Food Safety and Inspection Service – for USDA-approved facilities in the USA.

Thanks to this technology, we can carry out audits with on-site sessions lasting 2 hours, segmented into multiple sessions until the checklist is completed. This approach significantly minimizes the temporal intrusiveness, eliminates auditor travel costs, and reduces the environmental impact of travel.

  • Audits with on-site sessions lasting 2 hours, divided into multiple sessions until the checklist is completed.

  • Substantial reduction in the temporal intrusion of an audit.

  • Elimination of auditor travel costs.

  • Elimination of environmental impact due to the absence of travel.

Request information on our Audit services