Regulatory Actions
When the FDA identifies regulatory violations during an inspection, they issue 483 Observations and, in more serious cases, Warning Letters. These communications highlight areas where a company is not in compliance with FDA regulations and require prompt and effective remediation to avoid further regulatory actions.
At REJIMUS, we specialize in assisting companies in navigating the complexities of FDA Warning Letters and 483 Observations. Our goal is to guide you through every step of the process, ensuring that your response and corrective actions meet FDA expectations and lead to a successful closeout.
We offer a comprehensive range of services to address all aspects of FDA compliance, tailored to the specific violations or observations made. Our services include:
• Audits: Conducting thorough internal audits to identify and rectify compliance gaps before they escalate.
• Corrective and Preventive Actions (CAPAs): Developing and implementing effective CAPAs to address the root causes of non-compliance.
• Standard Operating Procedures (SOPs): Creating, reviewing, and updating SOPs to ensure they align with current regulatory requirements.
• Raw Material Specifications: Establishing and verifying raw material specifications to ensure quality and compliance.
• Finished Product Specifications: Defining and validating specifications for finished products to meet regulatory standards.
• Label Reviews: Ensuring product labels are accurate and comply with FDA regulations to avoid misbranding issues.
• Website Reviews: Evaluating and updating website content to ensure all claims are substantiated and compliant with FDA guidelines.
• Material Reviews: Reviewing all marketing and promotional materials to ensure compliance and accuracy.
Every Warning Letter or 483 Observation is unique, and the services required to address them may vary. We offer tailored solutions based on the specific issues identified by the FDA. Our experienced team can support additional services as needed, ensuring a comprehensive approach to achieving compliance. Whether it involves detailed risk assessments, training programs for your staff, or strategic planning to prevent future violations, our experts are equipped to provide the guidance and support you need.
Our commitment to excellence means we stay current with FDA regulations and industry best practices, ensuring that our clients are always ahead of the curve. Trust REJIMUS to be your partner in navigating the regulatory landscape, mitigating risks, and maintaining compliance, so you can focus on what you do best: delivering high-quality products to your customers.