How To Avoid Fines And Penalties By Registering With ANVISA?

According to ANVISA data, 80% of fines are due to avoidable failures. Learn about the main ones:

1. Expired or irregular licenses (AFE/AE)
   The lack of a Company Operating Permit (AFE) or its renewal after the deadline is the main cause of interdictions. In 2025, 35% of fines imposed were related to this non-compliance.
   • Solution: Implement a digital renewal calendar with alerts 90 days before expiration.
2. Products without registration or outdated notification
   Selling non-compliant items (such as prohibited supplements) results in immediate seizure and fines of up to R$ 500,000.
   • Solution: Check the status of registrations on the ANVISA portal monthly and use real-time traceability systems.
3. Non-compliant labeling
   Missing information, unproven health claims, or incorrect pictograms result in sales suspension.
   • Solution: Adopt digital checklists aligned with RDC 47/2009 and IN 289/2024.
4. Failures in good manufacturing practices (GMP)
   Incomplete documentation, insufficient hygiene controls, or unrecorded training account for 40% of audit rejections.
   • Solution: Train teams quarterly and digitize cleaning and quality control records.

Inspections can occur at any time, triggered by reports, technical complaints, or monitoring programs. In 2025, ANVISA intensified the use of digital data cross-checking to target inspections.

Steps to avoid fines during inspections:

• Keep documents accessible: AFE, GMP manuals, product records, and reports should be organized in the cloud for immediate presentation.
• Simulate internal audits: Test critical items such as product expiration dates, storage conditions, and equipment hygiene on a monthly basis.
• Train teams for interactions with inspectors: Employees should know how to direct questions to the technical manager, avoiding contradictory answers.

Key fact: Companies that conduct preventive audits reduce the incidence of fines by 70%.

I WANT TO BE PREPARED FOR AUDITS

If your company receives a tax assessment notice, it is essential to act quickly!

• Technical response within deadlines: You have between 10 and 30 days to submit an administrative defense. Include supporting documents (e.g., photos of corrections, reports) and highlight any procedural errors in the notification.
• Smart installment plans: Consolidated debts can be paid in up to 60 installments via the SISPAR System, with reduced interest rates for cash payments.
• Emergency requalification: Correct flaws before reinspection—such as training teams or adjusting labels—to demonstrate good faith and reduce penalties.

ATTENTION: Fines that are not contested within the deadline become final and may be registered as outstanding debt.

Turn fine prevention into a lever for growth. Stone Okamont offers integrated solutions for your company:

• Vulnerability diagnosis: We map gaps in documents, processes, and infrastructure based on the latest inspection criteria.
• Proactive deadline management: We monitor AFE expiry dates, registrations, and BPF certifications, avoiding oversights that generate 45% of fines.
• Audit preparation: We conduct simulations with checklists based on real cases and train teams to answer technical questions. 

With Stone Okamont, you can turn regulatory requirements into market opportunities. Request an audit and discover how our personalized consulting services protect your business while optimizing results.