ANVISA Inspection: be ready for the agency's visit.
We prepare your company for ANVISA health inspections and Good Manufacturing Practice certification (CBPF), with an initial assessment, gap remediation and support during the inspection.
What we deliver
We bring your facility to an inspection-ready state and reduce the risk of nonconformities.
RDC 665/2022 (GMP) compliance assessment with gap analysis.
Mock inspection with findings categorised by severity.
An action plan and CAPA to address gaps.
Team preparation and document organisation for the visit.
Technical support during the inspection and in responding to the final report.
Deliverables
What you receive
A gap analysis report with a prioritised action plan.
A mock inspection report in the format expected by the agency.
Documentation and evidence organised for the inspection.
Support in responding to nonconformities and obtaining/renewing CBPF.
References
Reference standards
- RDC 665/2022 - Good Manufacturing Practices for medical devices.
- RDC 658/2022 and other applicable GMP requirements.
FAQ
Frequently asked questions
Let's talk
ANVISA inspection scheduled or CBPF application approaching?
We conduct a mock inspection and bring your facility to an inspection-ready state.
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