Increased Inspections: How to Avoid Fines Due to Regulatory Failures with Anvisa and Inmetro
July 15, 2025
Regulatory inspections targeting companies that deal with regulated products are becoming increasingly strict.
If you are a CEO, manager, or technical lead at a company that manufactures, imports, or distributes products subject to regulation, it is time to ask yourself:
Is your company prepared for an inspection by local health authorities (Visa), Anvisa, or Inmetro?
In this article, we will cover:
- The main regulatory mistakes that lead to fines;
- The legal and commercial consequences;
- How to take preventive action;
- And how Licempre can support your company in maintaining regulatory compliance.
Why Have Inspections Increased?
With the advancement of digital systems, Anvisa and Inmetro now have real-time access to data, enabling them to cross-check registrations, certifications, and company information with greater efficiency.
In addition, new requirements such as UDI/SIUD by Anvisa and recent changes in certification processes have increased the need for companies to stay updated and well-prepared.
The 5 Most Common Regulatory Errors
- Expired or Irregular AFE (Company Operating Authorization)
The lack of a valid AFE is one of the leading causes of facility shutdowns and regulatory fines. - Unregistered Product or Outdated Notification
Products subject to sanitary regulation must be duly registered and kept up to date with Anvisa. - Non-Compliant Labeling
Failure to comply with current labeling standards may result in sales suspension or product seizure. - Expired Inmetro Conformity Certificate
Products such as tires, helmets, and household appliances must hold valid Inmetro certification. - Improper Hosting of Imported Products
Imported goods without active hosting cannot be legally marketed in Brazil.
What Are the Consequences of a Regulatory Fine?
- Fines that may exceed BRL 1 million
- Suspension of product sales
- Damage to the company’s reputation and brand image
- Loss of commercial contracts and bidding opportunities
- Operational shutdowns until compliance is restored
How to Avoid Regulatory Fines? A Practical Guide
Conduct regular internal audits
Proactively identify inconsistencies before an inspection takes place.
Organize and update your regulatory documentation.
Make sure all records are accessible and up to date: including AFE, certificates, registrations, and product labels.
Stay informed about changes in health and technical regulations.
Anvisa and Inmetro frequently update their standards, directly affecting regulated industries.
Work with specialized consultants
Licempre helps ensure that your products and your company remain fully compliant at all times.
How Can Licempre Help Your Company?
- Regulatory audits and preventive consulting
- Regularization and renewal of Anvisa registrations and notifications
- Updating and maintenance of Inmetro certificates
- Legal hosting of imported products
- Legal representation for international companies and products in Brazil
With Licempre, your company operates with security, agility, and full regulatory compliance.
Contact Licempre
Need a regulatory diagnosis or preparing for an inspection?
Talk to our team and find out how to turn compliance into a competitive advantage.