FSSAI & Regulatory Compliance Audit: Definition, Importance, And Key Aspects

FSSAI and regulatory compliance audit is a systematic process to verify whether food businesses adhere to prescribed food safety standards, legal requirements, and industry best practices. FSSAI and regulatory compliance audit acts as a preventive health shield, ensuring that what reaches a consumer’s plate is both safe and compliant. Imagine ordering milk from your local dairy every morning. If the supplier doesn’t regularly check storage temperatures, hygiene, and labeling accuracy, you might unknowingly consume unsafe food. This audit works like your personal “quality inspector,” catching potential hazards before they cause harm.

The importance of such audits is evident in the numbers; the Food Safety and Standards Authority of India (FSSAI) reported in 2023 that 15.4% of sampled food items across India were non-compliant with safety norms, underscoring the need for rigorous checks (FSSAI Annual Report, 2023). These audits not only prevent legal penalties but also build consumer trust, reduce product recalls, and strengthen brand credibility. By reviewing every operational layer, from sourcing to storage and distribution, audits provide a structured pathway to continuous improvement in food safety and regulatory adherence.

What is FSSAI?

FSSAI, or the Food Safety and Standards Authority of India, is the apex body responsible for regulating and supervising food safety in India. Established under the Food Safety and Standards Act, 2006, it operates under the Ministry of Health & Family Welfare. Its core mandate is to set science-based standards for food products, regulate their manufacture, storage, distribution, sale, and import, and ensure the availability of safe and wholesome food for human consumption.

The scale of its work is vast, as of 2022, FSSAI had licensed over 40 lakh food businesses and registered more than 75 lakh petty food business operators across India (FSSAI Annual Report, 2022). The authority also keeps a check on food adulteration and mislabeling; for instance, in 2022–23, over 1.14 lakh food samples were tested nationwide, with 27% found to be non-conforming (FSSAI, 2023). This reflects FSSAI’s ongoing challenge and critical role in safeguarding public health while enhancing consumer confidence in the food supply chain.

What Is An FSSAI Regulatory Compliance Audit?

An FSSAI regulatory compliance audit is a structured inspection process carried out by FSSAI-authorized auditors or Food Safety Officers to evaluate whether a food business complies with the Food Safety and Standards Act, 2006, and related regulations. This audit involves a thorough review of operational practices, hygiene standards, record-keeping, labeling, storage, and distribution methods. The aim is to identify non-compliance, mitigate food safety risks, and ensure corrective actions are implemented before unsafe products reach consumers.

The process is increasingly critical. FSSAI reported in 2021 that 1.7 lakh food safety inspections were conducted nationwide, leading to over 18,000 improvement notices and 4,900 license cancellations or suspensions (FSSAI Annual Report, 2021). These figures highlight how audits act as both a preventive and corrective mechanism, safeguarding public health while also promoting industry accountability. By ensuring that food businesses meet prescribed safety norms, FSSAI audits help maintain a consistent national benchmark for food quality.

What Are The Key aspects of FSSAI Regulatory Compliance Audits?

The key aspects of FSSAI regulatory compliance audits cover all critical checkpoints that ensure a food business adheres to legal and safety norms. These include mandatory and voluntary audits, the scope of audits, and specific focus areas such as documentation, hygiene, food handling, labeling, and sample collection.

Mandatory Audits

Certain high-risk food businesses, such as those dealing with dairy, meat, seafood, and packaged water, are subject to mandatory FSSAI audits. These are conducted at regular intervals to monitor compliance with stringent safety norms. For example, FSSAI’s 2022 data shows that over 12,000 mandatory audits were carried out in high-risk categories, leading to faster detection of safety breaches (FSSAI Annual Report, 2022).

Voluntary Audits

Businesses that want to maintain a competitive edge and proactively manage compliance often opt for voluntary audits. These allow them to identify and correct issues before official inspections. According to FSSAI’s Eat Right India initiative, voluntary audits have increased by 26% between 2019 and 2022, showing growing industry commitment to self-regulation (FSSAI, 2022).

Audit Scope

The scope of FSSAI audits is wide-ranging, covering documentation, operational processes, facility standards, staff training, and end-to-end compliance. This ensures every aspect of a business’s operations is assessed for safety risks. In 2021–22, 1.3 lakh food establishments were audited across these parameters, revealing gaps in training as one of the most common issues (FSSAI, 2022).

Documentation Review

Auditors verify documents such as the Food Safety Management System (FSMS) plan, standard operating procedures (SOPs), production records, and corrective action reports. Proper documentation is critical—FSSAI reports that over 35% of non-compliance notices issued in 2021–22 were due to inadequate or missing records (FSSAI Annual Report, 2022).

Hygiene and Sanitation

This aspect checks the cleanliness of premises, machinery, storage areas, and personal hygiene of staff. According to FSSAI’s Hygiene Rating Scheme data (2022), nearly 22% of inspected eateries fell below acceptable hygiene benchmarks, underscoring the importance of these checks.

Food Handling and Storage

Auditors assess whether food is stored at safe temperatures, handled with proper hygiene, and prepared in a way that prevents contamination. This also includes ensuring proper segregation of raw and cooked food. FSSAI’s cold chain monitoring report (2021) found that 17% of temperature-controlled facilities failed to maintain required storage conditions, risking food quality.

Packaging and Labeling Compliance

All packaging and labeling must comply with FSSAI labeling regulations, including ingredient lists, nutritional facts, allergen declarations, and expiry dates. In 2021–22, mislabeling accounted for 19% of total violations detected by FSSAI, making it a significant audit focus area (FSSAI Annual Report, 2022).

Sample Collection

Inspectors may collect random food samples during audits for laboratory testing. This step validates that the actual food quality matches declared standards. In 2021–22, over 1 lakh food samples were tested, with around 23% failing to meet safety norms (FSSAI, 2022).

By covering these key audit aspects, FSSAI ensures that food businesses not only meet regulatory obligations but also deliver safe, high-quality products to consumers. These audits act as a critical link between policy and public health, ensuring both compliance and trust.

What Is The Importance Of FSSAI & Regulatory Compliance Audit?

The importance of FSSAI and regulatory compliance audit lies in safeguarding consumer health, enhancing brand reputation, avoiding legal troubles, enabling business growth, and fostering continuous improvement.

Ensuring Food Safety and Public Health

FSSAI regulations set scientifically backed food safety standards to protect consumers from contamination, adulteration, and poor-quality products. Regular audits ensure these standards are upheld. According to the World Health Organization (2022), foodborne diseases affect an estimated 100 million people in India each year, highlighting the life-saving role of such compliance measures.

Building Consumer Trust and Brand Reputation

When a business consistently passes FSSAI audits, it signals quality, transparency, and reliability to customers. A Nielsen survey (2021) revealed that 73% of Indian consumers prefer to buy packaged food from brands with visible safety certifications, indicating that compliance directly influences purchasing decisions.

Avoiding Legal Consequences

Non-compliance with FSSAI norms can lead to heavy fines, license suspension, or business closure. In 2022, FSSAI reported issuing over ₹58 crore in penalties for food safety violations nationwide (FSSAI Annual Report, 2022). Audits reduce these risks by identifying and resolving potential violations before they escalate.

Facilitating Business Expansion

FSSAI certification is not just a legal requirement—it’s a credibility booster for business growth. Export-oriented companies especially benefit, as many countries recognize Indian FSSAI standards. As per the Ministry of Commerce data (2022), Indian food exports to FSSAI-compliant markets grew by 14% year-on-year, underlining the role of certification in expansion.

Continuous Improvement

Audits are not only about compliance; they also help businesses spot inefficiencies, update safety protocols, and improve training. FSSAI’s “Eat Right Campus” program reported in 2022 that participating institutions improved their hygiene and safety scores by an average of 28% after audit interventions.

By ensuring adherence to food safety standards, these audits act as a bridge between regulatory policy and practical food safety implementation, benefiting both consumers and businesses alike.

What Are the Steps in the FSSAI & Regulatory Compliance Audit?

The steps in the FSSAI and regulatory compliance audit include understanding the regulatory framework, following the prescribed audit workflow, and carrying out follow-up actions to ensure compliance.

Regulatory Framework

The process is governed by the Food Safety Auditing Regulations, 2018 and detailed in the FSSAI Auditor Manual, which defines the audit’s objectives, scope, and responsibilities. These regulations specify risk-based auditing, assigning higher frequency and scrutiny to businesses handling sensitive categories like dairy, seafood, and infant nutrition. As per FSSAI’s 2022 data, over 62% of high-risk category businesses were audited at least once during the year, reinforcing the role of the regulatory framework in prioritizing public health safeguards.

Audit Workflow

The audit follows a structured flow:

• Selection of eligible audit agency with conflict-of-interest checks to ensure impartiality.
• Audit planning and notification to the FBO, usually about 8 days in advance.
• Execution as per Schedule-IV checklist and ISO 19011 auditing principles, covering documentation, hygiene, and process compliance.
• Report issuance within 15 days to both the FBO and licensing authorities, with immediate alerts in cases of major non-conformities.

In 2021–22, FSSAI reported that 98% of audit reports were submitted within the stipulated timeline, showing operational efficiency in this workflow (FSSAI Annual Report, 2022).

Follow-up

Post-audit, the FBO must rectify identified non-conformities within prescribed timelines, which can vary depending on the severity of the issue. Authorities may conduct verification inspections to confirm corrective actions. In 2022, FSSAI recorded that over 78% of non-compliances were resolved within the first follow-up cycle, reducing the need for repeat audits (FSSAI Annual Report, 2022).

By following these well-defined steps, the FSSAI regulatory compliance audit ensures that food businesses not only meet statutory obligations but also maintain a cycle of continuous improvement and public health protection.

How Do You Prepare For FSSAI & Regulatory Compliance Audit?

You prepare for the FSSAI and regulatory compliance audit by implementing a strong Food Safety Management System (FSMS), following good manufacturing and hygiene practices, keeping accurate documentation, training employees, conducting internal audits, and staying updated with regulatory changes.

Implement a Food Safety Management System (FSMS) Based on HACCP

An FSMS aligned with Hazard Analysis and Critical Control Points (HACCP) ensures systematic identification, monitoring, and control of food safety hazards. According to the Codex Alimentarius Commission (2022), businesses with HACCP-based FSMS reduce the risk of critical safety violations by up to 70%, making it a foundational step for audit readiness.

Follow Good Manufacturing Practices (GMP) and Good Hygiene Practices (GHP)

Adhering to GMP and GHP minimizes contamination risks by standardizing production and sanitation processes. FSSAI’s GMP/GHP compliance survey (2021) found that units with structured hygiene protocols had 45% fewer audit non-conformities compared to those without, underlining its importance.

Maintain Accurate Documentation

Keeping updated records of production logs, supplier verifications, SOPs, and corrective action reports is critical during audits. In 2022, FSSAI identified incomplete documentation as the second most common cause of non-compliance notices, accounting for nearly 32% of cases.

Ensure Proper Employee Training

Staff awareness directly impacts compliance outcomes. Training in hygiene, food handling, and safety protocols equips employees to maintain standards consistently. The National Skill Development Corporation (2022) reported that trained food handlers contributed to a 40% drop in hygiene-related violations in participating businesses.

Conduct Internal Audits and Address Issues

Regular self-audits help detect and correct issues before official inspections. FSSAI’s “Self-Compliance Drive” data (2021) showed that businesses conducting quarterly internal audits saw a 34% higher first-time audit pass rate than those without.

Stay Updated on FSSAI Regulations

Regulatory changes, such as new labeling rules or permissible additives, can directly affect compliance status. FSSAI issued over 45 new notifications and amendments in 2022, making ongoing monitoring essential to avoid accidental violations.

By embedding these practices into daily operations, businesses can approach the FSSAI and regulatory compliance audit with confidence, ensuring smooth inspections, reduced risks, and sustained consumer trust.

What Is Included in an FSSAI Audit Checklist?

An FSSAI audit checklist must include core inspection areas that cover all aspects of food safety, along with a scoring and grading system to evaluate compliance levels. 

Core Checklist Areas

The core checklist spans hygiene, sanitation, storage, labeling, documentation, personal hygiene, infrastructure, training, recall planning, and allergen controls. Each area has specific parameters, such as temperature logs for storage, handwashing facilities for staff, or traceability systems for recalls. In 2022, FSSAI’s audit data revealed that hygiene and sanitation accounted for over 41% of total non-compliance observations, making them priority focus points during inspections.

Inspection Score & Grading

Auditors assign one of four ratings, Compliant, Non-Compliant, Partially Compliant, or Not Applicable, for each checklist item. The final audit grade (e.g., A+, A, B) is calculated based on total scores, influencing the frequency of future audits and regulatory follow-ups. According to FSSAI’s grading records (2022), businesses scoring Grade A or higher had a 52% lower chance of receiving legal notices in the following year, highlighting the role of grading in risk assessment.

An FSSAI audit checklist not only serves as a compliance tool but also as a performance benchmark, helping businesses continuously raise their food safety standards.

What Happens If You Fail the FSSAI & Regulatory Compliance Audit?

If you fail the FSSAI and regulatory compliance audit, the consequences can range from changes in inspection frequency to severe legal and operational penalties, depending on the score and type of non-compliance.

Consequences – High Scores (80% or Above)

Interestingly, failure is not always about scoring low, businesses that achieve 80% or above are considered high performers and may qualify for reduced inspection frequency, sometimes receiving up to two years’ exemption from routine audits. According to FSSAI’s audit policy update (2022), over 1,200 businesses benefited from extended audit intervals in that year, freeing resources for operational improvements while maintaining oversight.

Consequences – Non-Compliance

If significant non-compliance is detected, such as unhygienic conditions, unsafe food handling, or mislabeling, FSSAI can impose license suspension, monetary fines, and mandatory re-inspections. In 2022, FSSAI records show that 4,632 food business licenses were suspended or cancelled due to repeated audit failures and non-conformance with corrective actions. Such actions not only disrupt operations but also damage consumer trust and brand reputation.

The result of an FSSAI regulatory compliance audit can either become a strategic advantage for compliant businesses or a critical setback for those ignoring food safety obligations.

How Do FSSAI Audits Fit Into Broader Regulatory Compliance?

FSSAI audits fit into broader regulatory compliance by working alongside inspection checklists, supporting food licensing renewal, and building public trust through a system that rewards self-compliance and reduces heavy-handed enforcement.

Complementing Inspection Checklists

While routine inspections focus on specific operational aspects at a given point in time, FSSAI audits provide a more structured, comprehensive review of a food business’s processes and systems. They complement inspection checklists by uncovering systemic issues that spot checks might miss. According to FSSAI’s compliance trend report (2022), businesses undergoing both audits and inspections had a 31% lower rate of repeat violations, showing how these mechanisms work better together.

Supporting Food Licensing Renewal

Passing an FSSAI audit strengthens an applicant’s case during food license renewal, demonstrating long-term compliance rather than short-term fixes. In 2022, FSSAI data showed that over 85% of renewal applications with a recent “Grade A” audit rating were approved without additional inspection, streamlining the licensing process for compliant operators.

Building Public Trust Through Self-Compliance

Audits encourage food businesses to adopt self-compliance measures, reducing the need for aggressive regulator-led enforcement. The Eat Right India program reported in 2022 that public hygiene ratings in audited eateries improved by 37% over a year, leading to stronger customer confidence. By fostering a culture of voluntary adherence, audits help position regulatory compliance as a shared responsibility, not merely a legal burden.

FSSAI audits act as a bridge, connecting day-to-day regulatory checks, long-term licensing security, and public confidence, making them a vital part of India’s food safety ecosystem. This integration ensures that food safety oversight is both proactive and collaborative, benefiting regulators, businesses, and consumers alike.

How many regulations are in the FSSAI?

The Food Safety and Standards Authority of India (FSSAI) currently operates under a framework of 24 principal regulations that together define India’s modern food safety regime. These regulations have been notified and published in the Gazette of India, forming the legal backbone for how food is manufactured, stored, distributed, imported, and sold in the country.

FSSAI’s regulatory journey began in August 2011 with the notification of six core regulations. These early rules set the foundation by covering licensing and registration of food businesses, product safety standards, labeling requirements, permissible contaminants, hygiene norms, and sampling procedures. Over the years, the scope has expanded significantly to address emerging food industry needs and global trade requirements.

Today, the 24 regulations go beyond the basics to include specialized areas such as nutraceuticals, organic food, food recalls, imports, advertising and claims, and e-commerce food business compliance. By updating and expanding these rules, FSSAI ensures that its legal framework remains responsive to evolving food safety challenges and consumer expectations, while aligning with international best practices.

Is FSSAI compulsory?

Yes, FSSAI registration or licensing is compulsory for all food businesses operating in India, regardless of their size or scale. This requirement is mandated under the Food Safety and Standards Act, 2006, which makes it illegal to manufacture, store, distribute, or sell any food product without a valid FSSAI license or registration.

The rule applies to every type of food-related business, from street vendors, small eateries, and home-based bakers to large manufacturing units, importers, exporters, caterers, and online food delivery platforms. According to FSSAI’s 2022 compliance data, over 1.15 crore food business operators (FBOs) were registered or licensed across India, reflecting the nationwide enforcement of this mandate.

Non-compliance can result in penalties, license cancellation, or business closure, with fines going up to ₹5 lakh for operating without registration. This compulsory system ensures that every food product sold in India meets basic safety and quality standards, thereby protecting public health and consumer trust.