October 17, 2024

At Maven, we understand the critical importance of adhering to regulatory requirements, particularly for manufacturers of low-acid canned foods (LACF) and aseptically processed products. Non-compliance with FDA regulations, as outlined in 21 CFR Part 108 and 113, can result in severe consequences, including product recalls, the issuance of emergency permits, and legal actions. Maven offers comprehensive toxicology risk assessment and regulatory services to help manufacturers meet these stringent standards, ensuring both compliance and product safety.

Here’s how our services help manufacturers like yours overcome compliance challenges and safeguard the quality of your products:

1. Regulatory Compliance Consulting

Navigating the complex world of FDA regulations can be daunting. Maven offers expert guidance to ensure your facility and processes meet all necessary legal standards. Our services include:

  • Gap Analysis: A thorough evaluation of your current manufacturing processes to identify any deviations from FDA regulations.
  • Process Filing and Registration Assistance: We help you with filing processes and registrations under 21 CFR 108, preventing the need for emergency permits and ensuring regulatory compliance.
  • Risk Assessment: Tailored risk assessments for low-acid food products, ensuring that they comply with both U.S. and global regulatory standards.

2. Process Optimization and Validation

Ensuring the proper monitoring of critical factors, such as temperature and pressure, is key to the success of LACF production. Maven supports you in optimizing and validating your processes through:

  • Process Validation: Establishing and validating critical parameters to ensure your aseptic filling and packaging systems meet regulatory standards.
  • Real-time Monitoring: Implementing real-time systems to monitor crucial factors like temperature seals to prevent contamination.
  • Ongoing Audits: Continuously reviewing and auditing production records to ensure completeness, accuracy, and compliance with regulatory requirements.

3. Corrective Actions and Risk Mitigation

Manufacturing facilities often face challenges such as fluctuating steam supplies or equipment malfunctions. Maven provides expert solutions by offering:

  • Root Cause Analysis: Identifying and resolving deviations from scheduled processes.
  • Corrective and Preventive Actions (CAPA): Addressing issues like improper monitoring of critical factors or failures in sterility maintenance.
  • Facility and Equipment Recommendations: Offering guidance on facility expansion and equipment upgrades to ensure consistent production quality and regulatory adherence.

4. Microbiological Testing and Food Safety Assurance

Maven helps manufacturers ensure the microbiological safety of their products through:

  • Validation of Microbiological Testing: Validating methods such as ATP testing and standard plate counts to confirm commercial sterility.
  • Consulting with Process Authorities: Working with experts to evaluate product safety when test results exceed established limits.
  • Quality Control Procedures: Establishing robust quality control processes to prevent contamination and ensure product safety before reaching the market.

5. Documentation and Training

Ensuring long-term compliance requires proper documentation and staff training. Maven supports this by:

  • Documentation Reviews: Reviewing critical processing records to ensure completeness and compliance with regulatory timelines.
  • Training Programs: Offering comprehensive training for staff on regulatory standards, focusing on the maintenance and monitoring of critical factors during production.

Overcoming FDA Warnings

When faced with FDA warnings, prompt and effective action is crucial. Maven provides tailored support to help manufacturers navigate these challenges efficiently. Here are key steps we implement to assist you:

  1. Immediate Assessment: Maven conducts a thorough internal review to understand the basis of the FDA warning and identify the specific areas needing attention, ensuring a clear path forward.
  2. Implement Corrective Actions: We help you develop and implement a robust Corrective and Preventive Action (CAPA) plan tailored to address the specific issues identified by the FDA, minimizing the risk of future non-compliance.
  3. Enhance Training Programs: Our team offers specialized training sessions for your staff, reinforcing compliance with FDA regulations and internal quality standards, thus empowering your workforce to uphold best practices.
  4. Increase Monitoring and Reporting: Maven assists in establishing more stringent monitoring processes and regular reporting mechanisms to ensure ongoing compliance and swiftly identify any potential deviations.
  5. Engage with Regulatory Experts: We leverage our network of regulatory experts to help you understand the implications of the warning and navigate the response process effectively, ensuring that all aspects are covered.
  6. Document Everything: Maven emphasizes the importance of thorough documentation. We support you in maintaining detailed records of all corrective actions taken, training conducted, and changes implemented, demonstrating your commitment to compliance to the FDA.

Conclusion

By partnering with Maven, manufacturers can meet FDA requirements, safeguard product quality, and avoid potential legal risks. Maven’s expert consulting services provide peace of mind, ensuring your LACF products remain safe, compliant, and of the highest quality.

Let Maven guide you through every step of the process, from compliance to quality control, ensuring your operations run smoothly and your products meet all necessary safety standards. Reach out to us today to learn how we can support your compliance efforts and enhance the quality of your products.